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

Stopped early · Phase 2

Conditions studied: High Grade Glioma

In brief

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.

Key facts

Study ID

NCT00003535

Run by

Burzynski Research Institute

People needed

9

Starts

1994-04-01

Expected to finish

1998-01-01

Last updated by the study team

2018-03-21

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burzynski Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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