Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer. PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer.

Detailed Description
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OBJECTIVES: Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate alone, in terms of objective tumor response, in women with advanced breast cancer. Compare the adverse effects of and tolerance to these regimens in these patients. OUTLINE: This is a randomized study. Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules 7 times daily until the maximum tolerated dose is reached, followed by oral methotrexate capsules 2 to 3 times per day in five days on and five days off courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I. Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6. PROJECTED ACCRUAL: A total of 30-70 patients will be accrued for this study within at least 12 months.

Official Title
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Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules 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: methotrexate
* Procedure: alternative product therapy
* Procedure: biological therapy
* Procedure: biologically based therapies
* Procedure: cancer prevention intervention
* Procedure: chemotherapy
* Procedure: complementary and alternative therapy
* Procedure: differentiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed advanced breast cancer that is refractory or unlikely to respond to hormonal therapy AND failed at least 1 prior chemotherapy regimen Symptomatic lymphangitic pulmonary dissemination allowed Extensive visceral metastasis allowed Patients who are refractory or who have failed to respond after at least 8 weeks of methotrexate or a methotrexate-containing regimen are not eligible Measurable disease No bone metastases Hormone receptor status: Estrogen receptor negative PATIENT CHARACTERISTICS: Age: Postmenopausal Sex: Female Menopausal status: Postmenopausal Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT no greater than 2 times normal Blood ammonia normal No hepatic failure Renal: BUN less than 60 mg/dL Creatinine no greater than 2.5 mg/dL Creatinine clearance greater than 60 mL/min No chronic renal failure Cardiovascular: No severe heart disease Pulmonary: No severe lung disease Other: No serious active infections or fever No other concurrent serious disease No prior or concurrent secondary malignancies within the past 2 years Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent biologic therapy for metastatic breast cancer Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy and recovered No other concurrent chemotherapy for metastatic breast cancer Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy for metastatic breast cancer Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy for metastatic breast cancer Surgery: Not specified Other: At least 4 weeks since prior participation in experimental clinical trials No prior antineoplaston A10 therapy No other concurrent treatment for metastatic breast cancer No concurrent salicylates, nonsteroidal anti-inflammatory drugs, phenylbutazone, phenytoin, and sulfonamides
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: methotrexate|nan|
|Procedure: alternative product therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: biologically based therapies|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: chemotherapy|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 |
| --- | --- | --- |