Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast

Status Terminated

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 studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.

Clinical Trial Description

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with Stage IV breast cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).

• To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV breast cancer.

• To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV Breast Cancer

• NCT number: NCT00003454
• Study type: Interventional
• Source: Burzynski Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: March 18, 1996
• Completion date: December 28, 2002