Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003455
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Withdrawn
Phase	Phase 2

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