Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma

Oligodendroglioma, Adult Clinical Trial

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

Status Terminated

Clinical Trial Summary

RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.

Clinical Trial Description

OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive oligodendrogliomas 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.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in adults with recurrent/progressive oligodendrogliomas, 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/progressive oligodendrogliomas.

• 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

• Oligodendroglioma
• Oligodendroglioma, Adult

• NCT number: NCT00003472
• Study type: Interventional
• Source: Burzynski Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: May 1996
• Completion date: September 2007