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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003475 |
RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with primary malignant brain tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | February 1996 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Patients are followed at least every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed incurable primary malignant brain tumor that has progressed during or is recurrent after prior initial therapy, including radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
Burzynski Clinic | Recruiting |
Houston, Texas, United States, 77055-6330 | |
Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 info@burzynskiclinic.com |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Responsible Party: | Burzynski Clinic ( Stanislaw R. Burzynski ) |
Study ID Numbers: | CDR0000066512, BC-BT-21 |
Study First Received: | November 1, 1999 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003475 |
Health Authority: | Unspecified |
recurrent adult brain tumor adult medulloblastoma adult glioblastoma adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult central nervous system germ cell tumor adult subependymoma adult ependymoblastoma |
adult pineoblastoma adult meningeal hemangiopericytoma adult choroid plexus tumor adult grade III meningioma adult grade II meningioma adult giant cell glioblastoma adult gliosarcoma adult supratentorial primitive neuroectodermal tumor (PNET) adult pineal gland astrocytoma |
Choroid Plexus Neoplasms Glioblastoma Neuroectodermal Tumors, Primitive Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Hemangiopericytoma Recurrence Ependymoma |
Brain Neoplasms Neuroectodermal Tumors Medulloblastoma Neuroepithelioma Oligodendroglioma Meningioma Choroid Plexus neoplasms Gliosarcoma Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases |