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| Sponsor: | Burzynski Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003457 |
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 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 Patients With Brain Tumors |
| Study Start Date: | July 1996 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: 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 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Patients achieving partial response or stable disease continue treatment until disease progression.
Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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 | 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 |
More Information
| Responsible Party: | Burzynski Clinic ( Stanislaw R. Burzynski ) |
| Study ID Numbers: | CDR0000066489, BC-BT-9 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003457 History of Changes |
| Health Authority: | Unspecified |
|
ACTH-producing pituitary tumor TSH producing pituitary tumor recurrent adult brain tumor adult brain stem glioma adult craniopharyngioma adult medulloblastoma adult meningioma adult glioblastoma adult anaplastic astrocytoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma |
adult central nervous system germ cell tumor adult pilocytic astrocytoma adult subependymoma adult ependymoblastoma adult pineocytoma adult pineoblastoma adult meningeal hemangiopericytoma adult choroid plexus tumor adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma adult pineal gland astrocytoma |
|
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |