Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

NCT00003455 | Withdrawn Phase 2

• 2 other identifiers: BC-BR-14CDR0000066487
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IV Breast Cancer; Recurrent Breast Cancer

Interventions

antineoplaston A10 DRUG

antineoplaston AS2-1 DRUG

alternative product therapy PROCEDURE

biological therapy PROCEDURE

biologically based therapies PROCEDURE

cancer prevention intervention PROCEDURE

complementary and alternative therapy PROCEDURE

differentiation therapy PROCEDURE

Eligibility Criteria

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

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

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; antineoplaston AS 2-1; Biological Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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)