Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
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 progressive or recurrent stage IV melanoma.
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 Malignant Melanoma|
- Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
|Study Start Date:||March 1996|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma.
- Describe response, 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 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Tumors are measured every 2 months for the first year and every 3 months for the second year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|