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Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Patients With Ependymoma

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Trial Identification

Brief Title: Antineoplaston Therapy in Treating Patients With Ependymoma

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma

Study ID: NCT00003479

Conditions

Ependymoma

Study Description

Brief Summary: RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma . PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.

Detailed Description: OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with ependymoma 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 patients with ependymoma OVERVIEW: This is a single arm, open-label study in which patients with ependymoma 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 to this study

Eligibility

Minimum Age: 6 Months

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Burzynski Clinic, Houston, Texas, United States

Contact Details

Name: Stanislaw R. Burzynski, MD, PhD

Affiliation: Burzynski Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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