Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

Study Description

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

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial