Antineoplaston Therapy in Treating Patients With Ependymoma

Ependymoma Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Ependymoma

• NCT number: NCT00003479
• Study type: Interventional
• Source: Burzynski Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: July 1966
• Completion date: October 2000