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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003476 |
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 children 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 Children With Primary Malignant Brain Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | March 1996 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy
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: | CDR0000066513, BC-BT-22 |
Study First Received: | November 1, 1999 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003476 |
Health Authority: | Unspecified |
childhood low-grade cerebral astrocytoma childhood craniopharyngioma childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor childhood grade I meningioma |
childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma recurrent childhood pineoblastoma |
Choroid Plexus Neoplasms Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Ependymoma Recurrence Brain Neoplasms |
Medulloblastoma Craniopharyngioma Oligodendroglioma Meningioma Glioma Choroid Plexus neoplasms Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases |