Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003455
• Other study ID #: BC-BR-14
• Secondary ID: CDR0000066487
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 9, 2013

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Intervention

Drug:
• antineoplaston A10

• antineoplaston AS2-1

Procedure:
• alternative product therapy

• biological therapy

• biologically based therapies

• cancer prevention intervention

• complementary and alternative therapy

• differentiation therapy

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States,