Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced Breast Cancer
antineoplaston A10
+ antineoplaston AS2-1
+ alternative product therapy
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location