Expired Study
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Houston, Texas 77055


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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.


Study summary:

OBJECTIVES: - Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme. - Describe response, tolerance to, and side effects of this regimen in these patients. OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Tumors are measured every 2 months during the first year and every 3 months during the second year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) - Measurable disease by MRI or CT scan - Brain stem tumor is excluded - Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No liver failure - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit Renal: - No history of renal conditions that contraindicate high dosages of sodium - Creatinine no greater than 2.5 mg/dL Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease (e.g., severe COPD) Other: - Not pregnant or nursing - Fertile patients must use adequate contraception during and for 4 weeks after study - No active infection - No other serious medical or psychiatric conditions PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since chemotherapy (unless radiologically proven progression) - At least 6 weeks since nitrosoureas Endocrine therapy: - Corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since radiotherapy (unless radiologically proven progression) Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agent allowed


NCT ID:

NCT00003474


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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