Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

• Status: Terminated
• Trial end date: 1998-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high grade gliomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

Inclusion Criteria:

• Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy

• Measurable tumor by MRI scan performed within two weeks prior to study entry

• Male or female patients

• Children 6 months to 17 years

• Performance status: Karnofsky 60-100%

• Life expectancy of at least 2 months

• WBC greater than 1,500/mm^3

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

• No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal

• Must have recovered from adverse effect of previous therapy

• At least 8 weeks elapsed since last dose of radiation

• At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)

• Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function

• Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study

Exclusion Criteria:

• Prior A10 and AS2-1 treatment

• Severe heart disease

• Uncontrolled hypertension

• Lung disease

• Hepatic failure

• Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug.

• Pregnant or nursing

• Serious concurrent disease

• Concurrent antineoplastic or immunomodulatory agents