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 patients with brain tumors.


Study summary:

OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors. - Describe response to, tolerance to, and side effects of this regimen in these patients. 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


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists - Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography - Tumor must be at least 5 mm - Ineligible for other BRI brain tumor protocols PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - Hemoglobin at least 9 g/dL - 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 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 - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry) Radiotherapy: - At least 8 weeks since prior radiotherapy Surgery: - Must recover from prior surgery Other: - Prior cytodifferentiating agent allowed - No prior antineoplaston therapy


NCT ID:

NCT00003457


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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