Overview

This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date May 1996
End date December 2011
Trial size 40 participants
Trial identifier NCT00003472, BC-BT-17, CDR0000066509

Summary

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 recurrent or refractory oligodendroglioma after previous chemotherapy, radiation therapy, and/or biological therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate based on tumor measurements taken at 12 weeks
time frame:

Secondary Outcomes

Measure
Survival at 1, 2, and 5 years from the start of treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy - Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - Must have received and failed prior standard therapy (i.e., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No severe heart disease - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infections - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - Recovered from any prior surgery Other: - No prior antineoplaston therapy

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma
Description OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory oligodendroglioma. - Describe response to, tolerance to, and side effects of this regimen in these patients. 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 3 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. Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).