Burzynski: Progression-Free Survival

http://www.burzynskiclinic.com/scientific-publications.html
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Interim Reports on Clinial Trials:

1. 10/2003

NEURO-ONCOLOGY

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003

10/2003 – Protocol – children with recurrent and progressive MULTICENTRIC GLIOMA

12 – Children Patients Accrued
10 – Evaluable Patients
(9 months – 17 years / 9 – median age)

Patients had 2 to 7 tumors:
11 / 92% – bilateral tumors
7 / 58% – visual pathway gliomas with involvement of the optic chiasm
5 / 42% – low-grade astrocytoma
4 / 33% – involvement of the brain stem
4 / 33% – involvement of the spinal cord
2 / 17% – leptomeningeal spread
——————————————————————
# and % of Patients Showing Progressive Disease:
0 / 0%
——————————————————————
# and % of Patients Alive and Well (2 to 13 years Post Diagnosis):
10 / 100%
——————————————————————
3 – continue ANP

The study continues with accrual of additional patients
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Interim Reports on Clinial Trials:

16. 2003

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

BT-11 – BRAIN STEM GLIOMA

Special Exception (SE) to BT-11

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:

a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
Pg. 95

10 / 83% – BRAIN STEM GLIOMA
1 / 8% – GLIOMA of BRAIN STEM and thalamus
1 / 8% – ASTROCYTOMA

Pgs. 91 – 92

12 patients (6 males / 6 females – Pg. 95)
(4 – 29 years / 10 – median age: Pg. 95)
10 evaluable (Pg. 91)

Pgs. 91 – 92
——————————————————————
Of all 12 Patients:
——————————————————————
Survival at 2 years:
4 / 33.3%
——————————————————————
Alive and Tumor Free for over 5 years since Initial Diagnosis:
2 / 17%
——————————————————————
From start of Treatment:
5+ years – 1 alive
4+ years – 1 alive
——————————————————————
Median Survival: (Pg. 99)
7 months
======================================
Pg. 99

11 Evaluable Patients treated under Special Exception (SE) to BT-11
——————————————————————
Median Survival:
6.4 months
======================================
COMBINED: Antineoplastons (Pg. 99)
======================================
Median Survival:
7 months – BT-11
6.4 months – Special Exception (SE) to BT-11
======================================
Pgs. 91 and 100

Study continues with accrual of additional patients

Pg. 92

Owing to the long accrual process of all 40 patients necessary to complete the study, we decided to report the results of treatment of the 1st 12 patients diagnosed with recurrent diffuse intrinsic BRIAN STEM GLIOMA before completion of the study

Pg. 94

In all cases the responses were confirmed by radiologists not affiliated with Burzynski Clinic

All films of patients who obtained Complete Response (CR) and Partial Response (PR) were evaluated by radiologists and oncologists of the FDA
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Review Articles on Clinical Trials:

1. 3/2004

INTEGRATIVE CANCER THERAPIES

The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964

Pg. 48

6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME

– Patients Accrued
– Evaluable Patients
——————————————————————
Median Overall Survival from start of Treatment (OST) with the Majority of Patients Alive:
5.1 years
——————————————————————
Deceased or Status Unknown:
26%
——————————————————————
Maximum Survival (MS):
17+ years
——————————————————————
Progression-Free Survival (PFS):
1 Patient – Progressed after 24 months (2 years)
======================================
Pg. 47

2004 – Protocol – adenocarcinoma of the colon with liver metastases

– Patients Accrued
– Evaluable Patients
——————————————————————
# and % of Patients Survival Rate of more than 5 years:
/ 91%
versus
# and % of Patients Survival Rate of more than 5 years in controls on chemotherapy:
/ 39%
======================================
Pg. 50

6/1/2003 – Protocols – LOW-GRADE GLIOMA IN CHILDREN

BT-10 – 3. CHILDREN WITH BRAIN TUMORS

BT-11 – BRAIN STEM GLIOMA

BT-13 – 4. CHILDREN WITH LOW GRADE ASTROCYTOMA

BT-23 – 9. CHILDREN WITH VISUAL PATHWAY GLIOMA

CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES

19 – Evaluable Patients (7 – median age)
——————————————————————
Median Overall Survival from Diagnosis (OSD):
6.3 years
======================================
Pg. 51

6/1/2003 – Protocol – BRAIN STEM GLIOMA
(15 children / 3 adults: 11 – median age)

BT-11 – BRAIN STEM GLIOMA

BT-22 – 8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

12 / 67% – recurrence after radiation or chemotherapy
6 / 33% – No prior treatment

18 – Evaluable Patients
——————————————————————
Median Overall Survival from Diagnosis (OSD):
13.7 months (1 year 1.7 months)
——————————————————————
Median Overall Survival from start of Treatment (OST):
10.3 months
——————————————————————
Maximum Survival (MS):
7.5+ years
——————————————————————
Progression-Free Survival (PFS):
7 months
——————————————————————
% of responding Patients didn’t develop Progression:
43%
======================================
COMBINED: Antineoplastons
======================================
13.7 months (1 year 1.7 months) – Median Overall Survival from Diagnosis (OSD): 6/1/2003 – Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)

7 months – Median Survival: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 – BRAIN STEM GLIOMA (Pg. 99)

6.4 months – Median Survival: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BRAIN STEM GLIOMA Patients treated under Special Exception (SE) to BT-11 (Pg. 99)
——————————————————————
10.3 months – Median Overall Survival from start of Treatment (OST): 6/1/2003 – Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)

7 months – Median Survival: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pg. 99)

6.4 months – Median Survival: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: Patients treated under Special Exception (SE) to BT-11 (Pg. 99)
——————————————————————
7.5+ years – Maximum Survival (MS): 6/1/2003 – Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)

5+ years – 1 alive – From start of Treatment: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)

4+ years – 1 alive – From start of Treatment: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
——————————————————————
7 months – Progression-Free Survival (PFS): 6/1/2003 – Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)

2 / 17% – Alive and Tumor Free for over 5 years since Initial Diagnosis: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
——————————————————————
43% – % of responding Patients didn’t develop Progression: 6/1/2003 – Protocol – BT-11 – BRAIN STEM GLIOMA (Pg. 51)

2 / 17% – Alive and Tumor Free for over 5 years since Initial Diagnosis: 2003 patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: BT-11 (Pgs. 91-92)
======================================
Pg. 52

– Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA

10 – Evaluable Patients
——————————————————————
Longest Survival (the Patients are currently alive):
7+ years
======================================
Pgs. 52 – 53

6/1/2003- Protocol – BRAIN STEM GLIOMA
——————————————————————
Patients Surviving at 2 years:
42%
======================================
COMPARE COMBINED: Antineoplastons
======================================
4 / 33.3% – Survival at 2 years: 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pgs. 91-92)

42% – Patients Surviving at 2 years: 6/1/2003- Protocol – BRAIN STEM GLIOMA (Pgs. 52-53)
——————————————————————
2 / 17% – Alive and Tumor Free for over 5 years since Initial Diagnosis: 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pgs. 91-92)

7.5+ years – Maximum Survival (MS): 6/1/2003 – Protocol – BRAIN STEM GLIOMA BT-11 (Pg. 51)

7+ years – Longest Survival (the Patients are currently alive): 3/2004 – Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
——————————————————————
5+ years – 1 alive – From start of Treatment: 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pgs. 91-92)

4+ years – 1 alive – From start of Treatment: 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pgs. 91-92)

7.5+ years – Maximum Survival (MS): 6/1/2003 – Protocol – BRAIN STEM GLIOMA BT-11 (Pg. 51)

7+ years – Longest Survival (the Patients are currently alive): 3/2004 – Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
——————————————————————
7 months – Median Survival: BT-11 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pg. 99)

6.4 months – Median Survival: Special Exception (SE) to BT-11 2003 Protocol patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: (Pg. 99)

13.7 months (1 year 1.7 months) – Median Overall Survival from Diagnosis (OSD): 6/1/2003 – Protocol – BRAIN STEM GLIOMA BT-11 (Pg. 51)

10.3 months – Median Overall Survival from start of Treatment (OST): 6/1/2003 – Protocol – BRAIN STEM GLIOMA BT-11 (Pg. 51)
======================================
COMPARE: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

6/1992 – Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients

Patients Accrued:
130 – arm 1
64 – arm 2
108 – Evaluable Patients (3 – 21 – age)
——————————————————————
ARM 1:
Patients Surviving at 1 year:
40 / 30.9%
Patients Surviving at 2 years:
9 / 7.1%
——————————————————————
ARM 2:
Patients Surviving at 1 year:
17 / 27.0%
Patients Surviving at 2 years:
4 / 6.7%
——————————————————————
Median time to Disease
Progression:

ARM 1: 6 months
ARM 2: 5 months
——————————————————————
Median time to Death:
ARM 1: 8.5 months
ARM 2: 8 months
======================================
COMPARE COMBINED:
======================================
13.7 months (1 year 1.7 months) – Antineoplastons Median Overall Survival from Diagnosis (OSD): 6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

8.5 months – ARM 1: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
——————————————————————
10.3 months – Antineoplastons Median Overall Survival from start of Treatment (OST):
6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

8.5 months – ARM 1: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
——————————————————————
7.5+ years – Antineoplastons Maximum Survival (MS): 6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

7+ years – Antineoplastons Longest Survival (the Patients are currently alive): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
——————————————————————
7 months – Antineoplastons Progression-Free Survival (PFS): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)

6 months – ARM 1: Median time to Disease
Progression:
radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

5 months – ARM 2: Median time to Disease
Progression:
radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
——————————————————————
42% – Antineoplastons Patients Surviving at 2 years: 6/1/2003- Protocol – BRAIN STEM GLIOMA (Pgs. 52 – 53)

40 / 30.9% – ARM 1: Patients Surviving at 1 year: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

17 / 27.0% – ARM 2: Patients Surviving at 1 year: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

9 / 7.1% – ARM 1: Patients Surviving at 2 years: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

4 / 6.7% – ARM 2: Patients Surviving at 2 years: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
======================================
Pg. 58

65. Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
======================================
Pg. 53

6/1/2003 – Protocol – HIGH-GRADE GLIOMA

– Patients Accrued
– Evaluable Patients
——————————————————————
Median Overall Survival from Diagnosis (OSD):
3 years
——————————————————————
Median Overall Survival from start of Treatment (OST):
1.15 years
——————————————————————
Maximum Survival (MS):
12.5+ years
——————————————————————
Progression-Free Survival (PFS):
12 months (1 year)
——————————————————————
% of Objective Response (OR) Patients hadn’t had Progression:
61%
======================================
COMPARE: (Pg. 53)
======================================
Median Survival without Treatment:
17 months (1 year 5 months)
——————————————————————
with treatment, may approach:
3 years
——————————————————————
Median Survival for Recurrent Tumors: (Phuphanich, et al.) 2002 [66] (Pg. 58)
8 months
======================================
COMPARE COMBINED: (Pg. 53)
======================================
3 years – Antineoplastons Median Overall Survival from Diagnosis (OSD): 6/1/2003 – Protocol – HIGH-GRADE GLIOMA

3 years – with treatment, may approach:

17 months (1 year 5 months) – Median Survival without Treatment:

8 months – Median Survival for Recurrent Tumors: Protocol – recurrent high-grade glioma Low dose thalidomide and temodar. (Phuphanich, et al.) 2002 [66] (Pg. 58)
——————————————————————
1.15 years – Antineoplastons Median Overall Survival from start of Treatment (OST): 6/1/2003 – Protocol – HIGH-GRADE GLIOMA

17 months (1 year 5 months) – Median Survival without Treatment:

8 months – Median Survival for Recurrent Tumors: Protocol – recurrent high-grade glioma Low dose thalidomide and temodar. (Phuphanich, et al.) 2002 [66] (Pg. 58)
——————————————————————
12.5+ years – Antineoplastons Maximum Survival (MS): 6/1/2003 – Protocol – HIGH-GRADE GLIOMA

3 years – with treatment, may approach:
======================================
Pg. 58

66. Phuphanich S, Selph J, Snodgrass S, et al. Low dose thalidomide and temodar as salvage therapy for recurrent malignant GLIOMA. Neuro-Oncology. 2002;4:374.
======================================
Pg. 54

6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME

BT-06

BT-07 (BT-7) – PATIENTS WITH GLIOBLASTOMA MULTIFORME

BT-09 (BT-9) – 2. PATIENTS WITH BRAIN TUMORS

BT-10 – 3. CHILDREN WITH BRAIN TUMORS

BT-18 – 6. MIXED GLIOMA

BT-20 – ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME

BT-21 – 7. PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS

CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES

All patients underwent prior surgery:
70 / 87.5% – tumor resection
10 / 12.5% – biopsy only

59 / 74% – developed recurrence after or during radiation and chemotherapy

– Patients Accrued
80 – Evaluable Patients
(72 adults / 8 children / 46 – median age)
——————————————————————
Median Overall Survival from Diagnosis (OSD):
15 months (1 year 3 months)
——————————————————————
Median Overall Survival from start of Treatment (OST):
9 months
——————————————————————
Maximum Survival (MS):
11+ years
——————————————————————
Progression-Free Survival (PFS):
5 months
——————————————————————
% of Objective Response (OR) Patients hadn’t Progressed:
53%
======================================
COMPARE COMBINED: Antineoplastons
======================================
5.1 years – Median Overall Survival from start of Treatment (OST) with the Majority of Patients Alive: 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 48)

9 months – Median Overall Survival from start of Treatment (OST): 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 54)
——————————————————————
17+ years – Maximum Survival (MS): 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 48)

11+ years – Maximum Survival (MS): 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 54)
——————————————————————
2 years – 1 Patient – Progressed after 24 months Progression-Free Survival (PFS): 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 48)

5 months – Progression-Free Survival (PFS): 6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME (Pg. 54)
======================================
COMPARE COMBINED:
======================================
15 months (1 year 3 months) – Antineoplastons: Median Survival: 6/1/2003 – Protocol – glioma of the highest malignancy, recurrent GLIOBLASTOMA MULTIFORME (GBM) (Pg. 55)

6.5 months – Median Survival: recurrent GLIOBLASTOMA MULTIFORME (GBM) with newest forms of Chemotherapy (Prados et al.). [67] (Pg. 58)

4 months – no treatment
======================================
Pg. 58

67. Prados M, Schold SCJr, Fine HA, et al. A randomized, double-blind, placebo-controlled, phase 2 study of RMP-7 in combination with carboplatin administered intravenously for the treatment of recurrent malignant GLIOMA. Neuro-Oncology. 2003;5:96-103.
http://www.ncbi.nlm.nih.gov/pubmed/12672281/
Neuro Oncol. 2003 Apr;5(2):96-103.
http://www.ncbi.nlm.nih.gov/m/pubmed/12672281/
Department of Neurological Surgery, University of California San Francisco, USA.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920676/
122 patients:
——————————————————————
62 – carboplatin + x
Median Survival:
26.9 weeks (6.5 months)
——————————————————————
60 – carboplatin + placebo
Median Survival:
19.9 weeks (4 months 3.9 weeks)
======================================
COMPARE COMBINED:
======================================
15 months (1 year 3 months) – Antineoplastons: Median Survival: 6/1/2003 – Protocol – glioma of the highest malignancy, recurrent GLIOBLASTOMA MULTIFORME (GBM) (Pg. 55)

6.5 months (26.9 weeks) – Median Survival: recurrent GLIOBLASTOMA MULTIFORME (GBM) with newest forms of Chemotherapy (Prados et al.). 62 – carboplatin + x [67] (Pg. 58)

4 months 3.9 weeks (19.9 weeks) – Median Survival: recurrent GLIOBLASTOMA MULTIFORME (GBM) with newest forms of Chemotherapy (Prados et al.). 60 – carboplatin + placebo [67] (Pg. 58)

4 months – no treatment
======================================
Pg. 55

6/1/2003 – Protocol – GLIOBLASTOMA MULTIFORME

– Patients Accrued
– Evaluable Patients
——————————————————————
1 Surviving who exhibited Objective Response (OR):
11+ years
——————————————————————
Surviving:
9+ years
——————————————————————
3 Surviving:
3 years approximately
======================================
Pg. 48

Case Study, Patient 1

10 – age / male

10/1997 – inoperable low-grade astrocytoma grade 2 of the thalamus and brain stem

4/1998 – 3/1999 – treatment

11 months – Complete recovery (Pgs. 50 – 51)
——————————————————————
Pg. 51

Case Study, Patient 2

Less than 3 months old / female

10/1998 (10/13/1998)

Large brain stems glioma

Told would die within 1 month

4 months – treatment: contrast-enhancing tumor was no longer visible on Magnetic resonance imaging (MRI)

6 months – symptoms decreased / disappeared (Pg. 52)

5 years – completely normal and healthy (Pg. 52)
——————————————————————
Pg. 53

Case Study, Patient 3

54 – age / male

2/23/1996 – large high-grade malignant glioma (mixed astrocytoma, oligodendroglioma) tumor

3/27/1996 – 8/27/1997 – treatment (Pg. 54)

6+ years – tumor free (Pg. 54)
——————————————————————
Pg. 54

Case Study, Patient 4

41 – age / male

4/18/2000 – Anaplastic Astrocytoma (AA) high-grade glioma

2/22/2001 – 8/5/2001 – treatment

1/22/2003 – 3+ years after diagnosis – didn’t show any tumor recurrence
——————————————————————
Pg. 55

Case Study, Patient 5

26 – age / female

7/28/1994 – GLIOBLASTOMA MULTIFORME (GBM)

4/2/1996 – 7/29/1996 – treatment

9+ years from tumor diagnosis – survival / in good health
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Case Reports:

4. 9/2004

INTEGRATIVE CANCER THERAPIES

Special exception (SE) to BT-11

BRAIN STEM GLIOMA

Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748

40 – age / Caucasian male (Pgs. 257-258)

5/1999 – diagnosed (GBM) (Pg. 257)

2 months after completion of radiation therapy, admitted for antineoplaston treatment (Pg. 257)

9/30/1999 – admitted for administration of treatment (Pg. 258)

655 consecutive days of treatment with the exception of a few short interruptions (Pg. 257)

12/20/2000 – 1 year: Complete Response (CR) (Pg. 257)

8/21/2001 – treatment permanently discontinued due to resolution of tumor (Pg. 259)

4+ years – tumor free, able to carry on normal activities, and works full time (Pg. 257)
——————————————————————
Median Survival – Untreated Patients:
4 months
——————————————————————
Newest forms of chemotherapy:
Less than 7 months
——————————————————————
2 Patients have been Surviving Post Diagnosis:
7+ years
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Interim Reports on Clinial Trials:

2. 10/2004

NEURO-ONCOLOGY

BT-20 – Patients With GLIOBLASTOMA MULTIFORME (GBM)

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004

22 Evaluable Patients
(6 men / 16 women / 27 – 63 years /47 – median age)

5 / 23% – Multicentric tumors

20 / 91% – Surgery:
10 / 45.45% – tumor resection once
8 / 36.36% – tumor resection twice
2 / 9.09 – biopsy only

22 / 100% – radiation therapy
10 / 50% – chemotherapy

4.3 months – median duration of antineoplaston treatment
——————————————————————
Progression-Free Survival (PFS):
11 / 50% – 6 months
——————————————————————
Median Overall Survival:
9.2 months
——————————————————————
Maximum Overall Survival: (Pgs. 384-385)
8+ years
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Interim Reports on Clinial Trials:

3. 10/2004 (DBSG)

NEURO-ONCOLOGY

Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004

10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)

60 Patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))

46 / 77% – recurrent tumor after previous therapy

14 / 23% – progressive diffuse intrinsic brain stem glioma (DBSG) without prior treatment
——————————————————————
29 – Evaluable Patients:
——————————————————————
Overall Survival:
13 / 45% – 2 years
7 / 24% – 5 years
——————————————————————
Maximum Survival
(high-grade diffuse intrinsic BRAIN STEM GLIOMA (DBSG) recurrent after radiation and chemotherapy):

15.5+ years
======================================
31 – Evaluable Patients: Special Exception (SE)
——————————————————————
Survival:
10 / 32% – 2 years
5 / 16% – 5 years
——————————————————————
Maximum Survival
(high-grade diffuse intrinsic BRAIN STEM GLIOMA (DBSG) recurrent after radiation and chemotherapy):

11 years
——————————————————————
Progression-Free Survival (PFS):
12 / 41% – 1 year
9 / 29% – 1 year: Special exception (SE)
======================================
COMPARE: standard radiation therapy
——————————————————————
Survival at 2 years for newly diagnosed diffuse intrinsic BRAIN STEM GLIOMA (DBSG):
Less than 10%
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Interim Reports on Clinial Trials:

4. 10/2004 (AT/RT of CNS)

NEURO-ONCOLOGY

BT-14 – CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in CHILDREN WITH atypical teratoid/RHABDOID TUMORS (AT/RT) OF THE CENTRAL NERVOUS SYSTEM

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004

10/2004 – Protocol – CHILDREN WITH atypical teratoid / RHABDOID TUMORS (AT / RT) OF THE CENTRAL NERVOUS SYSTEM

10 / 91% – developed recurrent and progressive disease before antineoplaston treatment

1 / 9% – multiple metastases to the brain and spinal cord died due to aspiration pneumonia and was confirmed by autopsy as disease free

7 / 64% – single tumors

11 / 100% – previously treated with surgery
9 / 82% – chemotherapy
5 / 45%- radiation

1 / 9% – nonevaluable

3 / 27% – nonevaluable: Special Exception (SE)

5.7 months – average duration of treatment

11 – Children Patients Accrued
(7 treated under Special Exception (SE))
8 – Evaluable Patients

1 – complete response (CR) developed recurrence after premature discontinuation of treatment and obtained a 2nd complete response (CR) after treatment restarted
——————————————————————
Median Overall Survival Approximately:
9 months
——————————————————————
Median Survival from Prognosis with Antineoplastons:
17.1 months (1 year 5.1 months)
——————————————————————
Study continues, but accrual is slow due to rarity of AT/RT.
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Interim Reports on Clinial Trials:

5. 10/2004

NEURO-ONCOLOGY

BT-12 – Children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)

Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology

10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

17 – Patients Accrued
(12 months – 23 years / 6 – median age)
15 – Evaluable Patients

17 / 100% – recurrent disease or high-risk:
10 / 59% – Medulloblastoma
5 / 29% – pineoblastoma
2 / 12% – other primitive neuroectodermal tumors (PNET)

1 / 6% – involvement of the spinal cord

5 / 29% – multiple metastases

17 / 100% – resection

8 / 47% – chemotherapy
8 / 47% – radiation therapy

8 / 47% – high-risk didn’t receive prior chemotherapy and radiation

5 / 29% – not treated earlier with radiation therapy and chemotherapy

5.2 months – median antineoplaston administration

2 / 12% – nonevaluable due to lack of follow-up scans
——————————————————————
6 Alive and Well Post Diagnosis:
6+ – 10 years
——————————————————————
Median Survival from start of Antineoplaston Treatment:
20.6 months (1 year 8.6 months)
——————————————————————
from Diagnosis:
41.8 months (3 years 5.8 months)
——————————————————————
The study is ongoing and accruing additional patients
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Interim Reports on Clinial Trials:

17. 2004

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

Pg. 317

BT-13 – children with low-grade astrocytoma

BT-23 – children with visual pathway gliomas

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive MULTICENTRIC GLIOMA.

A Preliminary Report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R&D 2004;5(6):315-326.
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
Pgs. 315-316

12 Children Patients
(6 – males / 6 – females / 9 months – 17 years / 9 – median age)
10 evaluable (Pg. 315)

incurable recurrent and progressive multicentric glioma

Pgs. 315-316 and 318-319

8 / 67% – visual pathway glioma (Pgs. 318-319)
(1 / 8% – visual pathway glioma: biopsy not performed due to dangerous location)
6 / 50% – pilocytic astrocytoma
4 / 33% – low-grade astrocytoma
1 / 8% – astrocytoma grade 2

Pg. 316

Previous therapies:
4 / 33% – Surgery
4 / 33% – Surgery and chemotherapy
1 / 8% – Surgery, chemotherapy and radiation
1 / 8% – Chemotherapy and radiation
1 / 8% – Chemotherapy only

Pgs. 318-319

9 / 75% – Surgery (SU)
7 / 58% – Chemotherapy (CH)
2 / 17% – Radiation (RA)
2 / 17% – Biopsy only (Bx)

Pgs. 318-319

9 / 75.5% – Caucasian
1 / 8.5% – Asian Indian
1 / 8.5% – Latin American
1 / 8.5% – Oriental

progressive (without prior treatment) multicentric glioma (MCG)

Pg. 317 and 320

recurrent (progressive after prior treatment) multicentric glioma (MCG) previously treated with surgery, radiation therapy and / or chemotherapy

Pg. 315 and 320

16 months (1 year 4 months) – average duration of intravenous antineoplastons

19 months (1 year 7 months) – average duration of oral antineoplastons

1 / 8% – non-evaluable due to only 4 weeks of ANP and lack of follow-up scans and died while on treatment due to a non-hemorrhaging brain infarction and was considered a treatment failure

1 – had stable disease discontinued ANP against medical advice and died 4.5 years later

Pgs. 315 and 320-321
——————————————————————
Alive and Well from 2 to >14 years Post-Diagnosis:
10
——————————————————————
Pg. 320

3 – treated under Special Exception (SE) granted by the US FDA

Pgs. 317 and 320

7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive MULTICENTRIC GLIOMA (MCG)

Pg. 317

BT-13

children with low-grade astrocytoma

BT-23

children with visual pathway gliomas


Pgs. 317 and 320-321

12 – Patients Accrued
10 – Evaluable Patients
——————————————————————
Median Survival Post Diagnosis:
7 years approximately
——————————————————————
Median Overall Survival Post Diagnosis from initiation of Antineoplastons (ANP) with studies still ongoing:
5 years
——————————————————————
Median Progression-Free Survival (PFS):
5 years
——————————————————————
Pg. 321

3 – continue oral ANP

2 – expired

Pgs. 315 and 320

The study continues with ongoing accrual of additional new patients

Pg. 317

Responses confirmed by radiologists not affiliated with Burzynski Clinic (BC)

Radiologists and oncologists from FDA evaluated films and medical records of patients who obtained complete response (CR) and partial response (PR)

Responses confirmed by radiologists not affiliated with Burzynski Clinic (BC)
======================================
COMPARE COMBINED: Antineoplastons
======================================
5 years – Median Progression-Free Survival (PFS): 7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive MULTICENTRIC GLIOMA (MCG) (Pgs. 317 and 320) 3 – treated under Special Exception (SE) granted by the US FDA (Pg. 320) (Pgs. 317 and 320-321)

0 / 0% – # and % of Patients Showing Progressive Disease: 10/2003 – Protocol – MULTICENTRIC GLIOMA
——————————————————————
10 / 100% – Alive and Well from 2 to >14 years Post-Diagnosis: 7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive MULTICENTRIC GLIOMA (MCG) (Pgs. 317 and 320) 3 – treated under Special Exception (SE) granted by the US FDA (Pg. 320) (Pgs. 315 and 320-321)

10 / 100% – # and % of Patients Alive and Well (2 to 13 years Post Diagnosis): 10/2003 – Protocol – MULTICENTRIC GLIOMA
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Interim Reports on Clinial Trials:

18. 6/2005

INTEGRATIVE CANCER THERAPIES

BT-12 – children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES

Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMAL TUMORS treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Volume 4 Number 2 June 2005

Pgs. 168-171

13 Caucasian children patients – poor-risk recurrent disease or high risk
(10 males / 3 females – 1 – 11 years / 5 years 7 months – median age)

3 / 23% – younger than 3

10 – BT-12 (7 males / 3 females)
3 – CAN-01 (3 males)

Previous treatments:
12 / 92% – surgery (resections)
(1 / 8% – had biopsy only: suboccipital craniotomy)
6 / 46% – chemotherapy
6 / 46% – radiation therapy

6 / 46% – hadn’t received prior chemotherapy or radiation

20 months – average antineoplastons administered

Pgs. 168 and 170

8 / 62% – Medulloblastoma
3 / 23% – pineoblastoma
2 / 15% – other PRIMITIVE NEUROECTODERMALTUMORS (PNET)
(1 / 7.5% – PNET with neuronal and astrocytic differentiation / 1 / 7.5% – Supratentorial)

Pg. 169

12 / 92% – tumor progressed prior to ANP

8 / 62% – multiple cerebral metastases

1 / 7.5% – residual tumor after partial resection

1 / 7.5% – involvement of the spinal cord

Pgs. 169-170

CAN-01 study published. [2]
3 children with PNET were treated in this study – completed / closed for admission

Pg. 176

2. Burzynski SR, Conde AB, Peters A, et al. A retrospective study of antineoplastons A10 and AS2-1 in PRIMARY BRAIN TUMORS. Clin Drug Invest. 1999;18:1-10.
http://link.springer.com/article/10.2165%2F00044011-199918010-00001
Clinical Drug Investigation, July 1999, Volume 18, Issue 1, pp 1-10
http://link.springer.com/content/pdf/10.2165%2F00044011-199918010-00001.pdf

http://www.tlcdoctors.com/documents/aRetrospectiveStudyclinicalDrugInvestigation.pdf
Pgs. 168, 170 and 173
——————————————————————
Survived more than 5 years from Antineoplastons (ANP) Treatment
(5 weren’t treated earlier with radiation therapy or chemotherapy):

6 / 46%
======================================
COMPARE COMBINED: Antineoplastons
======================================
6 / 46% – Survived more than 5 years from Antineoplastons (ANP) Treatment: 6/2005 – BT-12 – children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
(5 weren’t treated earlier with radiation therapy or chemotherapy): (Pgs. 168, 170 and 173)

6 Alive and Well 6+ – 10 years Post Diagnosis: 10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
======================================
Pg. 170

The Group of Long-Term Survivors:
6 – children (5 males / 1 female)
Diagnosed from age 1 – 9
3 / 50% – medulloblastoma
1 / 16.66% – pineoblastoma
2 / 33.33% – other PNET
3 / 50% – disseminated disease
1 / 16.66% – involvement of brainstem
5 / 83.33% – prior subtotal tumor resection
1 / 16.66% – biopsy only: treated with combination chemotherapy
6 / 100% – didn’t have radiation therapy
——————————————————————
Pgs. 170 and 172

Case patient 1 – complete response (CR) passed away after 6 years, 10 months from start of ANP, 3 years after discontinuation of ANP: cause of death recurrent pneumonia, possibly due to chronic immunosuppression from chemotherapy administered prior to ANP

Pgs. 171- 173

Case patient 2 – stable disease (SD) / BT-12 / male / age 4 at admission / white / 5/28/1996 diagnosed (7/8/1996 – 3/25/1997 treatment: 256 days) / medulloblastoma / lost to follow-up after 6 years, 3 months, but believed to be alive since no confirmation of death

Case patient 8 – progressive disease (PD) / BT-12 / male / age 9 at admission / white / 10/16/1997 diagnosis (5/8/1998 – 11/3/1998 treatment: 157 days) / medulloblastoma / lost to follow-up after approximately 5 years, but believed to be alive since no confirmation of death
——————————————————————
3 – (7/27/2004) alive from 7+ – 10+ years from beginning of treatment
These 3 underwent partial tumor resection, but none were treated with chemotherapy and radiation therapy before antineoplastons (ANP)
Case patient 4 – complete response (CR) / BT-12 / female / age 1 at admission / white / 12/18/1996 diagnosis (2/27/1997 – 3/6/2003 treatment: 2,012 days) / pineoblastoma / off ANP / never treated with radiation therapy or chemotherapy / lives normal life for more than 7.5 years since ANP started

Case patient 5 – stable disease (SD) / BT-12 / male / age 9 at admission / white / 3/18/1997 admission (5/1/1997 – 1/27/1998 treatment: 163 days) / supratentorial / as a result of ANP and thereafter underwent radiation therapy

Case patient 11 – complete response (CR) / CAN-01 / male / age 2 at admission / white / 3/1/1994 admission (4/13/1994 – 6/16/1999 treatment: 952 days) / medulloblastoma / off ANP / never treated with radiation therapy or chemotherapy / lives normal life for more than 10 years, 4 months since ANP started

Pg. 172

479 – average days on treatment
157 – median days on treatment
======================================
COMPARE COMBINED: Antineoplastons
======================================
37.8 months (3 years 1.8 months) – Overall Survival from start (OSS) of Treatment: 4/13/1994 (4/13/1994 – 12/4/2001 as of 8/1/2004) Protocol – poor-risk recurrent disease or high risk 6/2005 – BT-12 study (Pgs. 168-170 and 176)

20.6 months (1 year 8.6 months) – Median Survival from start of Antineoplaston Treatment: 10/2004 – Protocol – BT-12 – Children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
——————————————————————
41.8 months (3 years 5.8 months) – Overall Survival from Diagnosis (OSD): 4/13/1994 (4/13/1994 – 12/4/2001 as of 8/1/2004) Protocol – poor-risk recurrent disease or high risk 6/2005 – BT-12 study (Pgs. 168-170 and 176)

41.8 months (3 years 5.8 months) – from Diagnosis: 10/2004 – Protocol – BT-12 – Children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

7. 7/2005

BT-11 – BRAIN STEM GLIOMA

Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs.
Neuro-Oncology. 2005; 7:300.
http://www.burzynskiclinic.com/images/stories/Publications/1224.pdf
Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting

2 trials (study and Special Exception (SE))

Intrinsic diffuse brain stem glioma (BSG)

10 assessable patients

Less than 4 years old
(3 months – 3 years)

7 / 70% – no biopsy: dangerous tumor location
2 / 20% – anaplastic astrocytoma
1 / 10% – pilocytic astrocytoma

4 / 40% – not treated prior to antineoplastons
3 / 30% – failed prior radiation and chemotherapy
2 / 20% – tumor resection
1 / 10% – stable disease after radiation

9.5 months – median duration of ANP administration
——————————————————————
Overall Survival at 2 years:
5 / 50%
——————————————————————
Overall Survival at 5 years:
2 / 20%
——————————————————————
Maximum Survival:
6+ years
======================================
COMPARE COMBINED:
======================================
5 years – 2 / 20% – Overall Survival at: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

2 years – 5 / 50% – Overall Survival: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

13.7 months (1 year 1.7 months) – Antineoplastons Median Overall Survival from Diagnosis (OSD): 6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

8.5 months – ARM 1: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
——————————————————————
5 years – 2 / 20% – Overall Survival: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

2 years – 5 / 50% – Overall Survival: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

10.3 months – Antineoplastons Median Overall Survival from start of Treatment (OST):
6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

8.5 months – ARM 1: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
——————————————————————
6+ years – Maximum Survival: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

7.5+ years – Antineoplastons Maximum Survival (MS): 6/1/2003 – Protocol – BRAIN STEM GLIOMA (Pg. 51)

7+ years – Antineoplastons Longest Survival (the Patients are currently alive): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)
——————————————————————
7 months – Antineoplastons Progression-Free Survival (PFS): Protocol – subgroup very difficult to treat recurrent diffuse intrinsic BRAIN STEM GLIOMA (Pg. 52)

6 months – ARM 1: Median time to Disease
Progression:
radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

5 months – ARM 2: Median time to Disease
Progression:
radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
—————————————————
6+ years – Maximum Survival: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

5 / 50% – Overall Survival at 2 years: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

42% – Antineoplastons Patients Surviving at 2 years: 6/1/2003- Protocol – BRAIN STEM GLIOMA (Pgs. 52 – 53)

2 / 20% – Overall Survival at 5 years: Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs 7/2005

40 / 30.9% – ARM 1: Patients Surviving at 1 year: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

17 / 27.0% – ARM 2: Patients Surviving at 1 year: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

9 / 7.1% – ARM 1: Patients Surviving at 2 years: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)

4 / 6.7% – ARM 2: Patients Surviving at 2 years: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997) 3/15/1999 [65] (Pg. 58)
======================================
Interim Reports on Clinial Trials:

19. 3/2006

BT-03


BT-11 – BRAIN STEM GLIOMA (BSG)

BT-18 – 6. MIXED GLIOMA / ADULT PATIENTS WITH MIXED GLIOMA: “mixed glioma”, a type of primary malignant brain tumor (PMBT)

BT-22 – 8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

CAN-01 (CAN-1) – PATIENTS WITH REFRACTORY MALIGNANCIES

Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA.
Integrative Cancer Therapies 2006;5(1):40-47
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
DOI: 10.1177/1534735405285380
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf

http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pgs. 40-41

4 phase 2 trials

BRAINSTEM GLIOMA (BSG)

patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma

recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem

Pgs. 40-43

14 – anaplastic HBSG (patients with inoperable tumor of high-grade pathology (HBSG))
(13 – Anaplastic astrocytoma (AA) / 1 – Anaplastic astrocytoma (AA) / mixed glioma)

4 – glioblastomas (gliobastoma multiforme (GBM)) (GBM / brain stem glioma (BSG))

14 – diffuse intrinsic tumors

12 – tumor recurrence

Previous therapies:
5 – surgery (SU)
4 – surgery (SU) / chemotherapy (CH) / radiation therapy (RA)
4 – surgery (SU) / radiation therapy (RA)
2 – biopsy (Bx) / chemotherapy (CH) / radiation therapy (RA)
1 – chemotherapy (CH) / radiation therapy (RA)
1 – biopsy (Bx) / radiation therapy (RA)
1 – biopsy (Bx)

6 – didn’t have radiation therapy or chemotherapy
(5 – underwent surgical resection / 1 – underwent biopsy only)

Pgs. 40-44

5 months – mediation duration of antineoplaston administration

216 – Average days on antineoplastons
154 – Median days on antineoplastons

18 patients (Pgs. 40-43)

Pgs. 42-43

(8 males / 10 females: 2 – 42 – years / 10 – median age)

Pg. 43

BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female

13 – DBSG
2 – Exophytic
1 – DBSG / multifocal
1 – Multifocal
1 – Cervico-medullary

Pg. 44

High-grade, recurrent, and progressive brainstem gliomas

Pgs. 40 and 45-46
——————————————————————
Most Patients with Newly Diagnosed High-Grade BRAIN STEM GLIOMAS (HBSG) don’t Survive more than:
2+ years
——————————————————————
Most Patients with BRAINSTEM GLIOMA fail standard radiation therapy and chemotherapy and don’t survive longer:
2 years
——————————————————————
Patients with Recurrent Tumors Survive no more than, despite standard treatment:
6 months
——————————————————————
Pgs. 40 and 44-45
——————————————————————
Patients with high-grade, recurrent and progressive BRAINSTEM GLIOMAS:
39% – Overall Survival at 2 years
22% – Overall Survival at 5 years
——————————————————————
Maximum Survival for Patient with recurrent, diffuse, intrinsic anaplastic ASTROCYTOMA:
17+ years (approaching 18 years)
——————————————————————
Patient with GLIOBLASTOMA
(6+ years – Patient with recurrent, diffuse, intrinsic GLIOBLASTOMA MULTIFORME (GBM)):

5+ years
——————————————————————
Survival in recurrent diffuse intrinsic GLIOBLASTOMAS and anaplastic ASTROCYTOMAS of the BRAINSTEM in a small group of Patients:
5+ years
——————————————————————
Patients with high-grade, recurrent and progressive BRAINSTEM GLIOMAS:
Progression-Free Survival (PFS) at 6 months:
39%
——————————————————————
Median Progression-Free Survival (PFS): (Pg. 45)
5.28 months
——————————————————————
12 – most likely tumor related deaths
3 – alive and tumor free
2 – aspiration pneumonia possible deaths
1 – death due to pulmonary embolism

Pgs. 40-42 and 44-45

7/12/1988 (7/12/1988 – 11/13/2003 as of 6/10/2005) – Protocol – recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem high-grade pathology (HBSG)

18 – Evaluable Patients

Pg. 42

BT-11 – ongoing: brain stem glioma (BSG)
BT-18 – ongoing: mixed gliomas (1 – diagnosed with mixed glioma of brainstem

BT-03 – completed. [14]
CAN-01 – completed. [15]

Pg. 47

14. Burzynski SR, Kubove E, Burzynski B. Phase II clinical trials of antineoplastons A10 and AS2-1 infusions in ASTROCYTOMA. In: Adam D, ed. Recent Advances in Chemotherapy. Munich, Germany: Futuramed; 1992

15. Burzynski SR, Conde AB, Peters A, et al. A retrospective study of antineoplastons A10 and AS2-1 in PRIMARY BRAIN TUMORS. Clin Drug Invest. 1999;18:1-10.
http://link.springer.com/article/10.2165%2F00044011-199918010-00001
Clinical Drug Investigation, July 1999, Volume 18, Issue 1, pp 1-10
http://link.springer.com/content/pdf/10.2165%2F00044011-199918010-00001.pdf

http://www.tlcdoctors.com/documents/aRetrospectiveStudyclinicalDrugInvestigation.pdf
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

8. 10/2006

BT-11 – BRAIN STEM GLIOMA

Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1.
Neuro-Oncology. 2006; 8:466.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)

10/2006 – Protocol – Brainstem gliomas and multicentric tumors (MBSG)

19 – Evaluable Patients
(3.9 – 40.8 years / 9.2 – median age)

(90% less than 18 years old)

95% – diffuse intrinsic brain stem glioma
5% – cervicomedullary tumor

37% – biopsy performed:
4 – low-grade glioma
3 – high-grade glioma

60% – Tumor recurrence after previous standard treatment

4.5 months – median duration antineoplastons
——————————————————————
Overall Survival Rate (OS):
53% – 1 year
32% – 2 years
16% – 5 years
——————————————————————
Progression-Free Survival Rate (PFS):
26% – 1 year
16% – 2 years
——————————————————————
Maximum Survival Rate:
9+ years
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

9. 4/2007 (NDBSG)

BT-11 – BRAIN STEM GLIOMA</strong

Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs.
Neuro-Oncology 2007; 9:206.
http://www.burzynskiclinic.com/images/stories/Publications/4021.pdf
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology

4/2007 – Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG)

20 – Evaluable Assessable Children Patients
(3 months – 20 years)

5 – high-grade gliomas

8 months – median duration of treatment
——————————————————————
Overall Survival (OS):
40% – 2 years
30% – 5 years
——————————————————————
Median Survival (MST):
16.4 months (1 year 4.4 months)
——————————————————————
Maximum Survival:
12+ years
——————————————————————
COMPARE: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999) (6/1992 – 10/1997)
——————————————————————
Overall Survival (OS):
7% – 2 year
0% – 5 year
——————————————————————
Median Survival (MST):
8.5 months
——————————————————————
Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
======================================
COMPARE COMBINED:
——————————————————————
Overall Survival (OS):
——————————————————————
40% – 2 years: Antineoplastons (ANP)

7% – 2 years: standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
30% – 5 years: Antineoplastons (ANP)

0% – 5 years: standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Median Survival (MST):
——————————————————————
16.4 months – Antineoplastons (ANP)

8.5 months – standard radiation therapy in combination with chemotherapy (RAT)
� � � � � � � � � � � � � � � � �
2007 – Recent clinical trials in diffuse intrinsic BRAINSTEM GLIOMA

Review Article

chart on page 172 (page 8 of PDF):
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2006 Adis – Pediatr Drugs 2006; 8 (3)

Pg. 172

Treatments for Astrocytic Tumors

Table II. Treatment of diffuse, intrinsic BRAINSTEM GLIOMA in children

Burzynski et al. [88] – Reference

Phase II – Study Type

(no. of pts) – pts = patients

RP (30 pts) – RP = recurrent and progressive tumor – Tumor type

ANP = antineoplastons A10 and AS2-1 – Treatment
——————————————————————
Overall Survival (OS) (%) – Efficacy:
46.7% – 2 year
30% – 5 year
——————————————————————
Median Survival Time (MST):
19.9 months (1 year 7.9 months)
——————————————————————
Pg. 177

88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA [abstract]. Neuro-oncol 2004; 6: 386

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive MULTICENTRIC GLIOMA : a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Pg. 172

Burzynski et al. [89] – Reference

Phase II – Study Type

(no. of pts) – pts = patients

RPS (10 pts) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type
{(66) = most in a study}

ANP = antineoplastons A10 and AS2-1 – Treatment
——————————————————————
Overall Survival (OS) (%) – Efficacy:
60% – 2 years
20% – 5 years
next best study
46.7% (30)
——————————————————————
Median Survival Time (MST):
26.3 months (2 years 2.3 months)
next best study:
19.9 months (1 year 7.9 months)
——————————————————————
(Above, I also provide the best next case to compare to)

Pg. 177

89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAS [abstract]. Neuro-oncol 2005; 7: 300

Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMAL TUMORS treated with antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Pg. 173

1.4.3 Targeted Therapy

“…multi-targeted therapy with ANP has shown promising results [12;88-91]”

Pg. 176

90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: a preliminary report. Drugs R D 2003; 4: 91-101

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA: a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive BRAIN STEM GLIOMA. Integr Cancer Ther 2006 Mar; 5 (1): 40-7


Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive BRAINSTEM GLIOMA.
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
30 evaluable patients with recurrent and progressive DBSG
——————————————————————
“>40% of patients survived for more than 2 years
30% more than 5 years.”

——————————————————————

[12,88]


Pg. 175

12. Burzynski SR Targeted therapy for BRAIN TUMORS In: Columbus, F editor. BRAIN CANCER research progress. New York: Nova Science Publishers Inc 2005

Pg. 173

10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant
[89]

——————————————————————
60% – 2-year survival rate
20% – 5-year survival rate
maximum survival more than 7 years

——————————————————————

[89]


“The results are compiled in table II.”

Pg. 174

2.3. Targeted Therapy

Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving

1652 adults
335 children
[147]


Pg. 178

147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006

Pg. 174

Long-term follow-up of children treated with ANP for ASTROCYTOMAS revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility
——————————————————————
>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients

——————————————————————
Pg. 169

1.1.4. Targeted Therapy

Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
and
AS2-1 have been reported
[39]
——————————————————————
small group of Patients with progressive LGA, ANP
——————————————————————
Median Survival:
7 years 9 months
——————————————————————
Maximum Survival:
15+ years
——————————————————————
[39]

LGA = Low-Grade ASTROCYTOMA

Table I. Selected chemotherapy regimens for the treatment of low-grade ASTROCYTOMA in children

Burzynski [39] – Reference

Phase II d – d = Preliminary results – Study type

P = progressive tumor – Tumor type

(no. of pts) – pts = patients

ANP (10 pts) – ANP = antineoplastons A10 and AS2-1 – Treatment
{(78) = most in a study}
——————————————————————
Overall Survival (OS) [%] – Efficacy:
100% (1 year)
90% (3 year)
——————————————————————
Median Survival Time (MST):
93 months
next closest:
96 (1 year)
——————————————————————
Progression-Free Survival (PFS) (%):
90% (1 year)
90% (3 years)
best other study:
100% (1 year)
68% (3 years)
——————————————————————
(Above, I also provide the best next case to compare to)

Pg. 176

39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for PRIMARY BRAIN TUMORS. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg

� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:

10. 6/2008 (OPG)

BT-23 – CHILDREN WITH VISUAL PATHWAY GLIOMA

Phase II study of antineoplastons A10 and AS2-1 (ANP) in CHILDREN WITH optic PATHWAY GLIOMA:

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf
Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008

7 / 58% – solitary tumors
5 / 42% – multicentric

5 / 42% – pilocytic astrocytoma
4 / 33% – low-grade astrocytoma
2 / 17% – neurofibromatosis 1

8 / 67% – failed chemotherapy alone
3 / 25% – didn’t have biopsy
2 / 17% – developed progression after surgery
2 / 17% – not treated prior but developed progressive tumors

16.5 months (1 year 4.5 months) – Median antineoplaston treatment

6/2008 – Protocol – CHILDREN WITH optic PATHWAY GLIOMA

12 Evaluable Children Patients
(7 months – 16 years / 6 years 3 months – Median age)
——————————————————————
0 – lost to follow-up
——————————————————————
3.5 – 15.2 years – alive and well postdiagnosis
——————————————————————
3 – 9.5 years – alive and well postenrollment
——————————————————————
45.4 months (3 years 9.4 months) – Median Interval of Disease Control
——————————————————————
42% – 5 year Overall Survival from Initiation of Treatment
——————————————————————
67% – 5 year Overall Survival from Time of Diagnosis
——————————————————————
13.7 years – Median Overall Survival from Diagnosis based on Kaplan-Meier Survival curve
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:

11. 10/2008

(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9)

(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
17)

Phase II study of antineoplastons A10 and AS2-1 (ANP) in PATIENTS WITH newly diagnosed ANAPLASTIC ASTROCYTOMA:

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf
Volume 10 Issue 5 October 2008
Neuro-Oncology 2008; 10:821
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology, November 20-23, 2008

Newly Diagnosed and Recurrent ANAPLASTIC ASTROCYTOMA (AA):
Normal 5-year Survival Rate:
Less than %30

FDA monitored study

14 / 70% – Biopsy only
6 / 30% – Surgery
0 / 0% – received radiation or chemotherapy before antineoplastons (ANP)

5.7 months – Median Duration of Treatment

10/2008 – Protocol – Patients with Newly Diagnosed ANAPLASTIC ASTROCYTOMA (AA)

20 Evaluable Patients
(22 – 64 years / 40 – Median age)
——————————————————————
45% – Overall Survival at 2 years
12.6 months (1 year .6 months) – Median Progression-Free Survival Time based on Kaplan-Meier
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:

12. 12/2008

(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 9)

(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 17)

Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in PATIENTS WITH recurrent ANAPLASTIC ASTROCYTOMA
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf
Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
Abstracts for the Eighth Congress of the European Association for Neuro-Oncology (EANO), Sept. 12-14, 2008, Barcelona, Spain

20 / 100% – tumor reoccurred in after radiation therapy
11 / 55% – received additional chemotherapy therapy before recurrence

6.5 months – Median duration of treatment

FDA-monitored phase II clinical trial

12/2008 – Protocol – ADULTS WITH recurrent ANAPLASTIC ASTROCYTOMA (AA)

20 – Evaluable Assessable Adult Patients
(20 – 51 years / 41 – Median age)
——————————————————————
ANAPLASTIC ASTROCYTOMA (AA) (WHO grade III):
less than 10% of all Gliomas
——————————————————————
5-year Survival Rate for Newly Diagnosed Patients:
Less than 30%
——————————————————————
Recurrent ANAPLASTIC ASTROCYTOMA (AA) Overall Survival :
Less than 2 years
——————————————————————
7 / 35% – Overall Survival (OS) at 2 years
——————————————————————
10.3 months – Median Progression-Free Survival based on Kaplan-Mieir
� � � � � � � � � � � � � � � � �
Case Reports:

1. 12/2009

BT-11 – BRAIN STEM GLIOMA special exception (SE)


Over a 10-year survival and complete response of a patient with diffuse intrinsic BRAINSTEM GLIOMA (DBSG) treated with antineoplastons (ANP).
Neuro-Oncology 2009; 11:923.
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan

8/12/1998 – 6 week old female Caucasian infant – diagnosed with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)

Tumor inoperable and pediatric oncology felt chemotherapy as well as radiation therapy wouldn’t be an option considering potential toxicity and age of patient

10/14/1998 – began IV antineoplaston (ANP) under FDA BT-11 special exception (SE)

2/1999 – achieved complete response (CR)

7/8/2000 – converted to oral (PO) antineoplaston (ANP)

7/8/2004 – permanently discontinued antineoplaston (ANP)
——————————————————————
11/2008 – 10.5 years old: father stated that clinically she was doing very well
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

13. 12/2009 (DBSG)

BT-11 – BRAIN STEM GLIOMA

Special exception (SE)

Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11.
Neuro-Oncology 2009, 11:951.
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan

12/2009 – Protocol – BRAINSTEM GLIOMAs

40 – Patients Accrued
(12 not evaluable due to short duration of treatment and lack of follow-up MRIs)
28 – Evaluable Patients (ST)
(23 children / 5 young adults)
——————————————————————
12 – newly diagnosed
16 – previously treated

Special exception (SE)

12/2009 – Protocol – BRAINSTEM GLIOMAs

52 – Evaluable Patients
(40 children / 12 young adults)
treated under special exception (SE)

18 – newly diagnosed

BT-11 and special exception (SE):
92% – diffuse intrinsic brainstem gliomas (DBSG)

Treatment median duration:
5.6 months – special exception (SE)
5.4 months – BT-11
——————————————————————
Overall survival (OS) – 2 years:
42% – special exception (SE)
36% – BT-11
——————————————————————
Overall survival (OS) – 5 years:
19% – special exception (SE)
25% – BT-11
======================================
COMPARE: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999) (6/1992 – 10/1997)

Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
——————————————————————
Overall survival (OS):
7% – 2 years
0% – 5 years
=====================================
COMPARE COMBINED:
——————————————————————
Overall survival (OS) – 2 years:
——————————————————————
42% – antineoplastons: special exception (SE)

36% – antineoplastons: BT-11

7% – standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Overall survival (OS) – 5 years:
——————————————————————
19% – antineoplastons: special exception (SE)

25% – antineoplastons: BT-11

0% – standard radiation therapy in combination with chemotherapy (RAT)
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:

15. 11/2010

BT-18 – ADULT PATIENTS WITH MIXED GLIOMA

Preliminary Results of a Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Recurrent Mixed Gliomas.
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf
Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010

7 / 35% – not evaluated due to inadequate duration of treatment and lack of follow-up Magnetic Resonance Imaging (MRI) scans

4.4 months – median duration of treatment

11/2010 – Protocol – Adult Patients with Recurrent Mixed Gliomas

20 – Children Patients Accrued
13 – Evaluable Patients
(9 men / 4 women: 29 – 54 years / 38 – Median age)
——————————————————————
Progression-Free Survival (PFS):
4 / 31% – 1 year
3 / 23% – 2 years
1 / 8% – 5 years
——————————————————————
Overall Survival (OS) from Diagnosis
12 / 92% – 1 year
11 / 85% – 2 years
6 / 46% – 5 years
——————————————————————
Overall Survival (OS) from
Start of Treatment

7 / 54% – 1 year
3 / 23% – 2 years
1 / 8% – 5 years

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