Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
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 studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast|
|Study Start Date:||August 1998|
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in women with stage IV breast carcinoma.
- Describe the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: 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 unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Tumors are measured at least every 2 months for 1 year and then every 3 months for 1 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: NCT00003454
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|