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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003458 |
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 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 Wtih Brain Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | September 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 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving 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 (except if medically contraindicated) severe pediatric brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists
Measurable tumor by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiation therapy:
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: | CDR0000066490, BC-BT-10 |
Study First Received: | November 1, 1999 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00003458 History of Changes |
Health Authority: | Unspecified |
childhood craniopharyngioma childhood central nervous system germ cell tumor childhood oligodendroglioma childhood choroid plexus tumor recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor |
recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma recurrent childhood pineoblastoma |
Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Ependymoma Recurrence Brain Neoplasms |
Neuroectodermal Tumors Brain Stem Glioma, Childhood Medulloblastoma Craniopharyngioma Neuroepithelioma Oligodendroglioma Glioma Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |