• Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ]
  

• Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
  

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

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