NCT00003455

Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage IV Breast Cancer
• Recurrent Breast Cancer

Interventions

Type	Name	Description
DRUG	antineoplaston A10
DRUG	antineoplaston AS2-1
PROCEDURE	alternative product therapy
PROCEDURE	biological therapy
PROCEDURE	biologically based therapies
PROCEDURE	cancer prevention intervention
PROCEDURE	complementary and alternative therapy
PROCEDURE	differentiation therapy

Timeline

• First posted: 2003-01-27
• Last updated: 2013-07-10

Locations

1 site across 1 country: United States