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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003474 |
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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme |
Estimated Enrollment: | 40 |
Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression.
Tumors are measured every 2 months during the first year and every 3 months during the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)
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 Research Institute | |
Houston, Texas, United States, 77055-6330 |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Study ID Numbers: | CDR0000066511, BRI-BT-20 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003474 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |