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

NCT00003536 | Withdrawn Phase 2

• 2 other identifiers: BC-BR-10CDR0000066584
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IV Breast Cancer; Recurrent Breast Cancer

Interventions

antineoplaston A10 DRUG

methotrexate DRUG

alternative product therapy PROCEDURE

biological therapy PROCEDURE

biologically based therapies PROCEDURE

cancer prevention intervention PROCEDURE

chemotherapy PROCEDURE

complementary and alternative therapy PROCEDURE

differentiation therapy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

antineoplaston A10; Methotrexate; Biological Therapy; Drug Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (1)