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

Burzynski Research Institute

Status and phase: Terminated; Phase 2

Conditions: High Grade Glioma

Treatments: Drug: Antineoplaston therapy (Atengenal + Astugenal)

Study type: Interventional

Funder types: Other

Identifiers

NCT00003535

CDR0000066582

BC-BT-06 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Antineoplaston therapy

Experimental group

Description:

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.

Treatment:

Drug: Antineoplaston therapy (Atengenal + Astugenal)