National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
Adverse Effects:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
� � � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
�
1. 10/2003
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA
�
A preliminary report
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003
�
12 patients
�
10 evaluable
�
1 – serious (grade 3) toxicity: reversible tinnitus
� � � � � � � � � � � � � � � � �
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
�
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
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
12 patients
�
10 evaluable
�
Pg. 96
�
Only mild and moderate toxicities were observed, which included:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatraemia
1 – agranulocytosis
1 – hypoglycaemia
1 – myalgia
1 – numbness
1 – tiredness
1 – vomiting
� � � � � � � � � � � � � � � � �
Review Articles on Clinical Trials:
�
1. 3/2004
�
INTEGRATIVE CANCER THERAPIES
�
Burzynski, S.R.
�
The Present State of Antineoplaston Research
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
�
Pg. 56
�
Adverse Reactions
�
Serious adverse reactions:
1.4% – anemia
0.5% – hypernatremia and fever
�
Moderate adverse reactions:
0.76% – skin rash
0.9% – slurred speech
�
Most patients experience increased diuresis, which may lead to dehydration and thirst
�
Adverse reactions observed have usually been transient and mild
�
Noted in our studies and due to phenylacetate, which is the main ingredient of AS2-1:
confusion
Reversible grade 1 somnolence
�
It’s suspected other adverse reactions observed in our studies were due to A10.
�
They weren’t observed by Buckner et al since they used approximately 50 times lower dosages of A10 in their study.
�
On the other hand, A10 induces diuresis, which may result in rapid elimination of AS2-1 through kidneys, which will lower concentration of AS2-1 in plasma and reduce chances for higher grade toxicity observed by Buckner et al. [49]
�
49. Burzynski SR. Efficacy of antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/pubmed/10377942/
Mayo Clin Proc. 1999;74:641-642.
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942/
Mayo Clin Proc. 1999 Jun;74(6):641-2.
http://www.sciencedirect.com/science/article/pii/S0025619611641438
Mayo Clinic Proceedings
Volume 74, Issue 6 , Page 641, June 1999
�
Buckner et al described:
reversible grade 2 or 3 neurological toxicity, consisting of:
confusion
exacerbation of an underlying seizure disorder
transient somnolence
[48]
�
48. Buckner JD, Malkin MG, Reed E, et al. Phase II study of antineoplaston A10 (NSC 648539) and AS2-1 (NSC 620061) in patients with recurrent glioma. Mayo Clin Proc. 1999;74:137-145.
http://www.ncbi.nlm.nih.gov/pubmed/10069350/
Mayo Clin Proc. 1999 Feb;74(2):137-45.
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350/
Mayo Clinic Proceedings
Volume 74, Issue 2, February 1999, Pages 137–145
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Department of Oncology, Mayo Clinic Rochester, Minnesota, USA.
� � � � � � � � � � � � � � � � �
Case Reports:
�
4. 9/2004
�
INTEGRATIVE CANCER THERAPIES
�
Special exception (SE) to BT-11
�
BRAIN STEM GLIOMA
�
Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.
�
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem GLIOBLASTOMA MULTIFORME
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748
�
Pg. 257
�
40 – age
�
Mild reversible side effects
�
Pg. 258
�
9/30/2009 – admitted for administration of treatment
Mild hypernatremia – On several occasions discontinued treatment from 1 to 3 days
Increased fatigue – off treatment 2 days
3/29/2000 – White blood cell (WBC) count decreased and discontinued treatment for 3 days
�
Pg. 259
�
7/10/2000 – White blood cell (WBC) count decreased and discontinued treatment until treatment restarted 7/13/2000
7/15/2000 – discontinued treatment elevation of transaminases (serum glutamic oxaloacetic transaminase; serum glutamic pyruvic transaminase) until restarted 7/28/2000
8/2001 – developed persistent diarrhea and was referred to a gastroenterologist, but there were no pathological findings except for changes related to obesity
8/21/2001 treatment discontinued due to resolution of tumor
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
2. 10/2004
�
NEURO-ONCOLOGY
�
BT-20
�
Patients With GLIOBLASTOMA MULTIFORME (GBM)
�
Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
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 /47 – median age)
�
Pg. 385
�
2 – grade toxicity: hypernatremia
2 – grade toxicity: somnolence
1 – grade 3 toxicity: anemia
1 – fatigue
1 – fever
1 – headache
1 – nausea
1 – tinnitus
1 – vomiting
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
3. 10/2004 (DBSG)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
�
60 patients
(31 treated under Special Exception)
�
1 – reversible grade 3 toxicity: anemia
1 – reversible grade 3 toxicity: hypertension
1 – reversible grade 3 toxicity: hypokalemia
1 – reversible grade 3 toxicity: neutropenia
1 – reversible grade 3 toxicity: allergic skin rash
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
4. 10/2004 (AT/RT of CNS)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
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
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
�
11 children patients
(7 treated under Special Exception)
�
8 evaluable
�
1 – serious toxicity: reversible hypernatremia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
5. 10/2004
�
NEURO-ONCOLOGY
�
BT-12
�
CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)
�
Preliminary results of phase II studies
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology
�
17 patients
(12 months – 23 / 6 – median age)
�
15 evaluable
�
1 – serious side effect: anemia
1 – serious side effect: fever
1 – serious side effect: granulocytopenia
� � � � � � � � � � � � � � � � �
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
�
Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMALTUMORS 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
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Pg. 168
�
13 children patients – recurrent disease or high risk
�
10 males / 3 females
�
(1 – 11 – age / 5 years, 7 months – median age)
�
3 – younger than 3
�
Pgs. 168 and 170
�
8 – Medulloblastoma
3 – pineoblastoma
2 – other PRIMITIVE NEUROECTODERMALTUMORS (PNET)
�
Pg. 168
�
10-BT-12 (7 males / 3 females)
�
3 – CAN-01 (3 males)
�
Pgs. 168 and 173
�
serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
7. 7/2005
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Burzynski, B., Jurida, G. Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs. Neuro-Oncology. 2005; 7:300.
Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting
�
2 trials
�
Intrinsic diffuse brain stem glioma (BSG)
�
10 assessable patients
�
Less than 4 years old
(3 months – 3 years)
�
7 – no biopsy: dangerous tumor location
2 – anaplastic astrocytoma
1 – pilocytic astrocytoma
�
Serious toxicities:
Reversible anemia
Hypokalemia
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-03
�
�
BT-11
�
BRAIN STEM GLIOMA (BSG)
�
BT-18
�
6. MIXED GLIOMA
�
ADULT PATIENTS WITH MIXED GLIOMA
�
“mixed glioma”, a type of PMBT
�
CAN-01
�
CAN-1
�
PATIENTS WITH REFRACTORY MALIGNANCIES
�
19. 3/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. 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://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pg. 40
�
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 – 41 and 42
�
4 – glioblastomas (gliobastoma multiforme (GBM)) (GBM / BSG)
�
14 – anaplastic HBSG (patients with inoperable tumor of high-grade pathology (HBSG)) (Anaplastic astrocytoma / Anaplastic astrocytoma/mixed glioma)
�
14 – diffuse intrinsic tumors
�
12 – recurrence
�
18 patients
�
Pg. 42
�
(8 males / 10 females)
�
2 – 42 – age (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
�
Pg. 44
�
High-grade, recurrent, and progressive brainstem gliomas
�
Pgs. 40 and 45
�
Antineoplastons tolerated very well
1 – grade 4 toxicity (reversible anemia)
�
Pg. 45
�
2 – grade 3 toxicities: reversible anemia
�
Generally, the treatment was well tolerated and was free from chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
8. 10/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006; 8:466.
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
�
Brainstem gliomas and multicentric tumors (MBSG)
�
19 evaluable patients
�
3.9 – 40.8 (9.2 – median age)
�
(90% less than 18 years old)
�
95% diffuse intrinsic brain stem glioma
5% cervicomedullary tumor
�
The patients didn’t experience any serious toxicities (grades III – IV), and there were no chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
9. 4/2007 (NDBSG)
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. 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.
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology
�
20 assessable children
�
3 months – 20 – age
�
5 – high-grade gliomas
�
Serious toxicities included:
5 – anemia
1 – elevation of transaminases
1 – hypokalemia
1 – skin rash
There were no chronic toxicities
� � � � � � � � � � � � � � � � �
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
Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008
�
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
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
——————————————————————
No grade 3 or 4 toxicities
� � � � � � � � � � � � � � � � �
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
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
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Weaver, Robert A.
�
FDA monitored study
�
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)
——————————————————————
2 / 10% – grade 3 toxicity possibly related to antineoplastons (ANP)
(Shortness of breath / generalized weakness)
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
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
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
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)
——————————————————————
1 / 5% – serious toxicity of hypernatremia
� � � � � � � � � � � � � � � � �
Case Reports:
�
BT-11 special exception (SE)
�
BRAIN STEM GLIOMA
�
1. 12/2009
�
Weaver, R.A., Szymkowski, B., Burzynski, S.R. 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.
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
�
10.5 – age / female
�
1 episode of grade 3 vomiting which resolved within 3 days
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
13. 12/2009 (DBSG)
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11. Neuro-Oncology 2009, 11:951.
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
�
40 patients
�
12 not evaluable
�
28 evaluable (ST) (23 children / 5 young adults)
�
12 – newly diagnosed / 16 previously treated)
�
Additional 52 evaluable (40 children / 12 young adults) treated under special exception (SE) (18 newly diagnosed)
�
ANP was well tolerated with serious toxicities occurring in less than 10% of patients in both groups:
anemia
dyspnea
elevated transaminases
fatigue
hypernatremia
hypokalemia
polyuria
skin rash
somnolence
subcutaneous extravasation
vomiting
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
14. 6/2010
�
BT-13 – CHILDREN WITH LOW GRADE ASTROCYTOMA
�
A Phase II Study of Antineoplaston A-10 and AS-1 Injections in CHILDREN WITH LOW-GRADE ASTROCYTOMAs.
Neuro-Oncology 2010; 12, ii95.
Volume 12 Issue 6 June 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
17 / 100% – Evaluable for Safety
�
12 or more weeks or at least 4 weeks of Antineoplastons (ANP) but developed Progressive Disease (PD)
Patients Evaluable for Efficacy
�
83 weeks – Median Antineoplastons (ANP) (15 / 100% – Evaluable Patients)
�
6/2010 – Protocol – CHILDREN WITH Recurrent and / or Progressive LOW-GRADE ASTROCYTOMA (LGA)
�
17 Patients Accrued
(20 months {1 year 8 months} – 210 months {17 years 6 months} / 129 months {10 years 9 months} – Median age)
15 Evaluable Patients
�
Patients Showing Stable Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
Patients Showing Progressive Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
——————————————————————
Minimal toxicity
� � � � � � � � � � � � � � � � �
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.
Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
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)
——————————————————————
Antineoplastons (ANP) was well tolerated with the most common side effects being:
Dysgeusia
Hypernatremia
Hypersensitivity
Myalgias
Nausea
Urinary frequency
�
1 – Serious (grade 3) toxicity (urinary frequency)
�
No grade 4 toxicities
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