Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists.

• - Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry.

• - Tumor must be at least 5 mm.

• - Ineligible for other Burzynski Research Institute, Inc.

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

OBJECTIVES:

• - To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors as measured by an objective response to therapy (complete response, partial response or stable disease).

• - To determine the safety and tolerance of Antineoplaston therapy in adults with persistent or recurrent brain tumors.

OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) 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 a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms

Experimental: Antineoplaston therapy

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Interventions

Drug: - Antineoplaston therapy (Atengenal + Astugenal)

Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).