Expired Study
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Houston, Texas 77055


Purpose:

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.


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


NCT ID:

NCT00003535


Primary Contact:

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


Backup Contact:

N/A


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: June 25, 2018

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