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 is studying how well antineoplaston therapy works in treating children with primary malignant brain tumors.


Study summary:

OBJECTIVES: - Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with primary malignant brain tumors by determining the proportion of patients who experience an objective tumor response. - Evaluate the adverse effects of and tolerance to this regimen in these children. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment. Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy - Must have failed prior standard therapy - No brain stem glioma - Evidence of tumor by MRI or CT scan PATIENT CHARACTERISTICS: Age: - 6 months to 17 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 1,500/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - No hepatic failure - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL Cardiovascular: - No severe heart disease - No uncontrolled hypertension Pulmonary: - No severe lung disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infections or fever - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Recovered from prior endocrine therapy - Concurrent corticosteroids for cerebral edema allowed Radiotherapy: - At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered Surgery: - At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered Other: - No prior antineoplaston therapy


NCT ID:

NCT00003476


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States

Stanislaw R. Burzynski, MD, PhD
Phone: 713-335-5697
Email: info@burzynskiclinic.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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