- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003455
Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced 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 is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77055-6330
- Burzynski Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
- Failed prior standard therapy
- Measurable disease by MRI or CT scan
- Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal Status:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal failure
Cardiovascular:
- No chronic heart failure
- No uncontrolled hypertension
Pulmonary:
- No severe lung disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No serious medical or psychiatric disorders
- No active infections
- No other serious concurrent disease
- No serious malabsorption syndromes
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
- At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy
Chemotherapy:
- Recovered from prior chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy
Endocrine therapy:
- Recovered from prior hormonal therapy
- At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
- Concurrent corticosteroids for peritumoral edema allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
- Patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks
Surgery:
- Recovered from any prior surgery
- No prior extensive stomach or intestinal surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplaston therapy
- No other concurrent therapy for metastatic breast cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-BR-14
- CDR0000066487 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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