Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

Mixed Gliomas Clinical Trial

Official title: Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma

Status Completed

Clinical Trial Summary

RATIONALE: Current therapies for adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

Clinical Trial Description

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas.

OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory mixed 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 to this study ;

Related Conditions & MeSH terms

• Glioma
• Mixed Gliomas

• NCT number: NCT00003473
• Study type: Interventional
• Source: Burzynski Research Institute
• Status: Completed
• Phase: Phase 2
• Start date: March 1996
• Completion date: August 2007