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 children with brain tumors.

Condition	Treatment or Intervention	Phase
childhood 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:

• Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with brain tumors by determining the proportion of patients who experience an objective tumor response.
• Evaluate the adverse effects of and tolerance to this regimen in these children.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Ages Eligible for Study:  up to  17 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed (except if medically contraindicated) severe pediatric brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists
• Histology requirement may be waived for brain stem tumors
• Measurable tumor or tumor markers by MRI or CT scan
• Tumor must be at least 5 mm

PATIENT CHARACTERISTICS: Age:

• 6 months to 17 years

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC greater than 2000/mm^3
• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and 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 history of heart failure
• No history of other cardiovascular conditions that contraindicate high dosages of sodium
• No uncontrolled hypertension

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) and recovered
• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry)

Radiation therapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from any prior surgery

Other:

• No prior antineoplaston therapy

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:  CDR0000066490; BC-BT-10; NCT00003458
Record last reviewed:  July 2004
Last Updated:  February 9, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003458
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08