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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003477 |
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 visual pathway glioma.
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 Infusions in Children With Visual Pathway Glioma |
Estimated Enrollment: | 40 |
Study Start Date: | June 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 antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.
PROJECTED ACCRUAL: Approximately 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 (unless medically contraindicated) visual pathway glioma that is unlikely to respond to existing therapy and for which no curative therapy exists
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: | CDR0000066514, BC-BT-23 |
Study First Received: | November 1, 1999 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003477 |
Health Authority: | Unspecified |
untreated childhood visual pathway glioma recurrent childhood visual pathway glioma |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma |
Central Nervous System Neoplasms Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |