Houston, Texas 77055

  • High Grade Glioma


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.

Study summary:

OBJECTIVES: - To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, as measured by an objective response to therapy (complete response, partial response or stable disease). - To determine the safety and tolerance of Antineoplaston therapy in children with recurrent/progressive high grade gliomas. OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.


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



Primary Contact:

Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute

Backup Contact:


Location Contact:

Houston, Texas 77055
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.