Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Recruitment status was: Recruiting
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.
|Adrenocortical Carcinoma||Drug: antineoplaston A10 Drug: antineoplaston AS2-1||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland|
- Response rate based on tumor measurements at 12 weeks
- Survival at 1, 2, and 5 years from the start of treatment
|Study Start Date:||August 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003453
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 email@example.com|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|