Antineoplaston Therapy in Treating Patients With Stage IV Bladder Cancer or Stage IV Newly Diagnosed, Incurable Bladder Cancer
Recruitment status was: Active, not 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 work in treating patients with stage IV bladder cancer or newly diagnosed stage IV bladder cancer.
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|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 Bladder|
- Tumor measurements at 12 weeks
- Survival at 1, 2, and 5 years from the start of treatment
|Study Start Date:||May 1996|
|Estimated Primary Completion Date:||August 2005 (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 bladder carcinoma or stage IV newly diagnosed, incurable bladder carcinoma.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 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.
X-rays or scans are performed every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003452
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|