Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced Breast Cancer

Conditions
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Stage IV Breast Cancer, Recurrent Breast Cancer

Intervention / Treatment
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* Drug: antineoplaston A10
* Drug: antineoplaston AS2-1
* Procedure: alternative product therapy
* Procedure: biological therapy
* Procedure: biologically based therapies
* Procedure: cancer prevention intervention
* Procedure: complementary and alternative therapy
* Procedure: differentiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antineoplaston A10|nan|
|Drug: antineoplaston AS2-1|nan|
|Procedure: alternative product therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: biologically based therapies|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: complementary and alternative therapy|nan|
|Procedure: differentiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |