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| Sponsor: | Burzynski Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003479 |
Purpose
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 ependymoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: This is an open label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily 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 stable disease may continue treatment.
Tumors are measured at least 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: A total of 20-40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ependymoma 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:
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00003479 History of Changes |
| Other Study ID Numbers: | CDR0000066516, BC-BT-24 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
adult ependymoma newly diagnosed childhood ependymoma recurrent childhood ependymoma adult anaplastic ependymoma |
|
Ependymoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |