Burzynski: The Original 72 Phase II Clinical Trials

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
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1 trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1

PATIENTS WITH REFRACTORY MALIGNANCIES
——————————————————————
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

Analysis has been made of patients with PRIMARY MALIGNANT BRAIN TUMORS (PMBT) in CAN-1 trial:

40 evaluable patients

17 experienced more than 50% reduction in size of tumors, of whom 7 had complete disappearance of tumor

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
=======================================
As of 10/1997, only 2 clinical trials have reached a Milestone
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“Clinical Trial BT-11”
——————————————————————
BT-11

PATIENTS WITH BRAIN STEM GLIOMA
——————————————————————
Another trial of Clinical Trial BT-11 involves patients with brain stem glioma

5/1996 trial approved by FDA

After accrual of 12 patients:

1 complete response
3 partial response
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“Clinical Trial BT-18”
——————————————————————
BT-18

ADULT PATIENTS WITH MIXED GLIOMA
——————————————————————
Clinical Trial BT-18

intravenous administration of Antineoplastons A10 and AS2-1 in

treatment of “mixed glioma”, a type of PRIMARY MALIGNANT BRAIN TUMORS (PMBT)
——————————————————————
3/1996 was approved by FDA

Results evaluated after 9 patients accrued:

2 complete responses
2 partial responses
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ACTIVE PHASE II CLINICAL TRIALS
=======================================
Title of Protocol

Subject of Protocol and Date

Number of Persons Enrolled

Number of Patients who may Participate in the Study
=======================================
AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND

2
40
——————————————————————
BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE BLADDER

3
40
——————————————————————
BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10

7
40
——————————————————————
BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE BREAST

17
40
——————————————————————
BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN

PATIENTS WITH ADVANCED BREAST CANCER

6
40
——————————————————————
BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

CHILDREN WITH HIGH GRADE GLIOMA

9
40
——————————————————————
BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH GLIOBLASTOMA MULTIFORME

34
40
——————————————————————
BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ANAPLASTIC ASTROCYTOMA

9
40
——————————————————————
BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRAIN TUMORS

11
40
——————————————————————
BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH BRAIN TUMORS

5
40
——————————————————————
BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRAIN STEM GLIOMA

15
40
——————————————————————
BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)

5
40
——————————————————————
BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH LOW GRADE ASTROCYTOMA

7
40
——————————————————————
BT-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

3
40
——————————————————————
BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA

17
40
——————————————————————
Pg. 7
=======================================
BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA

5
40
——————————————————————
BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH OLIGODENDROGLIOMA

5
40
——————————————————————
BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH MIXED GLIOMA

12
40
——————————————————————
BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA

0
40
——————————————————————
BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME

35
40
——————————————————————
BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS

19
40
——————————————————————
BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

4
40
——————————————————————
BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

CHILDREN WITH VISUAL PATHWAY GLIOMA

2
40
——————————————————————
BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH EPENDYMOMA

7
40
——————————————————————
BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CRANIOPHARYNGIOMA

0
40
——————————————————————
BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CHOROID PLEXUS NEOPLASM

1
40
——————————————————————
BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH GERM CELL TUMOR OF THE BRAIN

0
40
——————————————————————
BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH MENINGIOMA

2
40
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133
133
——————————————————————
CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE COLON

12
40
——————————————————————
CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN

PATIENTS WITH ADENOCARCINOMA OF THE COLON

4
40
——————————————————————
ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE ESOPHAGUS

4
40
——————————————————————
HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH HEPATOBLASTOMA

0
40
——————————————————————
Pg. 8
=======================================
HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN

PATIENTS WITH PRIMARY LIVER CANCER

1
40
——————————————————————
HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE HEAD AND NECK

6
40
——————————————————————
LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE LUNG

13
40
—————————————————————–
LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG

4
40
——————————————————————
LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG

1
40
—————————————————————–
LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG

5
40
——————————————————————
LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG

2
40
——————————————————————
LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN

PATIENTS WITH NON SMALL CELL LUNG CANCER

9
40
——————————————————————
LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA

2
40
——————————————————————
LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE

18
40
——————————————————————
LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE

10
40
——————————————————————
LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE

1
40
——————————————————————
LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MANTLE ZONE LYMPHOMA

4
40
——————————————————————
LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH

CHRONIC MYELOGENOUS LEUKEMIA

0
40
——————————————————————
LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME

0
40
——————————————————————
LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

0
40
——————————————————————
LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT

0
40
——————————————————————
LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

2
40
——————————————————————
Pg. 9
=======================================
MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MESOTHELIOMA

4
40
——————————————————————
ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MALIGNANT MELANOMA

8
40
——————————————————————
MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA

0
40
——————————————————————
MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MULTIPLE MYELOMA

5
40
——————————————————————
MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM

0
40
——————————————————————
NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NEUROBLASTOMA

1
40
——————————————————————
NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NEUROENDOCRINE TUMORS

3
40
——————————————————————
OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE OVARY

5
40
——————————————————————
PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE PANCREAS

11
40
——————————————————————
PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM

1
40
——————————————————————
PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

11
40
——————————————————————
PR-5 PHASE II STUDY OF

ADENOCARCINOMA OF THE PROSTATE

WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES

16
40
——————————————————————
PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

0
40
——————————————————————
PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

0
40
——————————————————————
RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE KIDNEY

9
40
——————————————————————
SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SOFT TISSUE SARCOMA

8
40
——————————————————————
SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE

1
40
——————————————————————
ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE STOMACH

6
40
——————————————————————
UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA

8
40
——————————————————————
10
=======================================
UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY

6
40
——————————————————————
WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH WILMS’ TUMOR

2
40
——————————————————————

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