Clinical Trial: Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland
Brief Summary:
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage IV adrenal gland cancer.
Detailed Summary:
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with stage IV adrenal gland carcinoma.
- Determine the tolerance to and side effects of this regimen in these patients.
- Determine the response in patients treated with this regimen.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV over a minimum of 1 hour 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Patients are followed every 2 months for the first year and then every 3 months for the second year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Sponsor: Burzynski Research Institute
Current Primary Outcome: Response rate based on tumor measurements at 12 weeks
Original Primary Outcome:
Current Secondary Outcome: Survival at 1, 2, and 5 years from the start of treatment
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 1, 1999
Date Started: August 1996
Date Completion:
Last Updated: June 9, 2009
Last Verified: June 2009
