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

Phase 2TerminatedNCT00003535

Burzynski Research Institute9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Grade Glioma

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Objective Response

Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.

Time frame: 12 months

Secondary Outcomes

Percentage of Participants Who Survived

6 months, 12 months, 24 months overall survival

Time frame: 6 months, 12 months, 24 months

Data from ClinicalTrials.gov

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