Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Burzynski Clinic

Stanislaw R. Burzynski

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003474
Information obtained from ClinicalTrials.gov on December 14, 2011

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