Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
- Conditions
- Stage IV Breast CancerRecurrent Breast Cancer
- Registration Number
- NCT00003455
- Lead Sponsor
- Burzynski Research Institute
- 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 women with stage IV breast cancer that has not responded to standard therapy.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response.
* Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day.
Treatment continues for at least 6 weeks. Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Burzynski Clinic
🇺🇸Houston, Texas, United States
Burzynski Clinic🇺🇸Houston, Texas, United States