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 primary malignant brain tumors.

Condition	Treatment or Intervention	Phase
adult brain tumor	Drug: antineoplaston A10  Drug: antineoplaston AS2-1  Procedure: alternative product therapy  Procedure: biological response modifier therapy  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: differentiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary malignant brain tumor that has progressed during or is recurrent or persistent after prior standard therapy, including radiotherapy and/or chemotherapy.
• Describe the response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Patients are followed at least every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed incurable primary malignant brain tumor that has progressed during or is recurrent after prior initial therapy, including radiotherapy
• Failed prior standard therapy
• Measurable disease by MRI or CT scan
• No brain stem tumors

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hematological function normal
• WBC at least 2000/mm^3
• Platelet count at least 50,000/mm^3

Hepatic:

• No liver failure
• No evidence of hepatic insufficiency
• Bilirubin no greater than 2.5 mg/dL
• SGOT/SGPT no greater than 5 times upper limit of normal

Renal:

• No evidence of renal insufficiency
• Creatinine no greater than 2.5 mg/dL
• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No uncontrolled hypertension
• No history of congestive heart failure
• No chronic heart failure
• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No medical or psychiatric illness that would preclude study treatment
• No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 4 weeks since prior immunotherapy
• No concurrent immunomodulating agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy
• At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy
• No concurrent antineoplastic agents

Endocrine therapy:

• Corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy

Surgery:

• At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy

Other:

• Recovered from prior therapy
• Cytodifferentiating agents allowed

Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000066512; BC-BT-21; NCT00003475
Record last reviewed:  July 2004
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003475
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08