Clinical Trial: Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma
Brief Summary:
RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.
Detailed Summary:
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma 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 anaplastic astrocytoma.
OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma 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
Sponsor: Burzynski Research Institute
Current Primary Outcome: Number of Participants With Objective Response [ Time Frame: 12 months ]
Original Primary Outcome:
Current Secondary Outcome: Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]
Original Secondary Outcome:
Information By: Burzynski Research Institute
Dates:
Date Received: November 1, 1999
Date Started: April 1995
Date Completion:
Last Updated: December 28, 2016
Last Verified: December 2016