Clinical Trial Finder

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

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.

Arms

Experimental: Antineoplaston therapy

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Interventions

Drug: - Antineoplaston therapy (Atengenal + Astugenal)

Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).