11/25/1997 – FORM 10-SB
Click to access 0000950110-97-001598.pdf
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1 trial that is retrospective is CAN-1 Clinical Trial
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CAN-1
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PATIENTS WITH REFRACTORY MALIGNANCIES
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Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
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Analysis has been made of patients with PRIMARY MALIGNANT BRAIN TUMORS (PMBT) in CAN-1 trial:
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40 evaluable patients
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17 experienced more than 50% reduction in size of tumors, of whom 7 had complete disappearance of tumor
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FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
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As of 10/1997, only 2 clinical trials have reached a Milestone
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“Clinical Trial BT-11”
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BT-11
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PATIENTS WITH BRAIN STEM GLIOMA
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Another trial of Clinical Trial BT-11 involves patients with brain stem glioma
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5/1996 trial approved by FDA
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After accrual of 12 patients:
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1 complete response
3 partial response
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“Clinical Trial BT-18”
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BT-18
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ADULT PATIENTS WITH MIXED GLIOMA
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Clinical Trial BT-18
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intravenous administration of Antineoplastons A10 and AS2-1 in
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treatment of “mixed glioma”, a type of PRIMARY MALIGNANT BRAIN TUMORS (PMBT)
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3/1996 was approved by FDA
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Results evaluated after 9 patients accrued:
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2 complete responses
2 partial responses
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ACTIVE PHASE II CLINICAL TRIALS
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Title of Protocol
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Subject of Protocol and Date
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Number of Persons Enrolled
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Number of Patients who may Participate in the Study
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AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
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2
40
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BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE BLADDER
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3
40
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BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10
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7
40
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BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE BREAST
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17
40
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BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN
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PATIENTS WITH ADVANCED BREAST CANCER
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6
40
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BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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CHILDREN WITH HIGH GRADE GLIOMA
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9
40
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BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH GLIOBLASTOMA MULTIFORME
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34
40
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BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ANAPLASTIC ASTROCYTOMA
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9
40
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BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH BRAIN TUMORS
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11
40
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BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH BRAIN TUMORS
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5
40
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BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH BRAIN STEM GLIOMA
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15
40
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BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)
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5
40
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BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH LOW GRADE ASTROCYTOMA
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7
40
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BT-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
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3
40
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BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
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17
40
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Pg. 7
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BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA
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5
40
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BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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ADULT PATIENTS WITH OLIGODENDROGLIOMA
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5
40
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BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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ADULT PATIENTS WITH MIXED GLIOMA
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12
40
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BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA
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0
40
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BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME
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35
40
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BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
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19
40
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BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
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4
40
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BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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CHILDREN WITH VISUAL PATHWAY GLIOMA
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2
40
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BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH EPENDYMOMA
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7
40
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BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH CRANIOPHARYNGIOMA
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0
40
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BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH CHOROID PLEXUS NEOPLASM
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1
40
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BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH GERM CELL TUMOR OF THE BRAIN
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0
40
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BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH MENINGIOMA
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2
40
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CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH REFRACTORY MALIGNANCIES
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133
133
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CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE COLON
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12
40
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CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN
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PATIENTS WITH ADENOCARCINOMA OF THE COLON
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4
40
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ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE ESOPHAGUS
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4
40
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HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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CHILDREN WITH HEPATOBLASTOMA
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0
40
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Pg. 8
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HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN
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PATIENTS WITH PRIMARY LIVER CANCER
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1
40
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HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE HEAD AND NECK
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6
40
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LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE LUNG
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13
40
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LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG
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4
40
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LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG
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1
40
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LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG
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5
40
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LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG
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2
40
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LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN
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PATIENTS WITH NON SMALL CELL LUNG CANCER
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9
40
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LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH NON-HODGKIN’S LYMPHOMA
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2
40
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LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE
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18
40
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LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE
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10
40
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LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE
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1
40
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LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH MANTLE ZONE LYMPHOMA
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4
40
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LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH
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CHRONIC MYELOGENOUS LEUKEMIA
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0
40
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LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME
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0
40
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LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
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0
40
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LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT
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0
40
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LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN
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PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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2
40
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Pg. 9
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MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH MESOTHELIOMA
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4
40
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ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH MALIGNANT MELANOMA
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8
40
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MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA
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0
40
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MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH MULTIPLE MYELOMA
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5
40
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MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM
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0
40
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NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH NEUROBLASTOMA
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1
40
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NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH NEUROENDOCRINE TUMORS
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3
40
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OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE OVARY
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5
40
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PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE PANCREAS
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11
40
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PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM
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1
40
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PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
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11
40
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PR-5 PHASE II STUDY OF
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ADENOCARCINOMA OF THE PROSTATE
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WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES
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16
40
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PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN
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PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
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0
40
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PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
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0
40
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RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE KIDNEY
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9
40
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SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH SOFT TISSUE SARCOMA
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8
40
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SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE
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1
40
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ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH ADENOCARCINOMA OF THE STOMACH
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6
40
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UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA
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8
40
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UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
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PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY
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6
40
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WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN
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PATIENTS WITH WILMS’ TUMOR
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2
40
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