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Spots Global Cancer Trial Database for A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases

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Trial Identification

Brief Title: A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases

Official Title: A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases

Study ID: NCT01939483

Study Description

Brief Summary: This pilot clinical trial studies irinotecan hydrochloride in treating patients with breast cancer and brain metastases that progressed after whole brain radiation therapy or stereotactic radiosurgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Description: PRIMARY OBJECTIVES; I. To evaluate the safety and efficacy of irinotecan (irinotecan hydrochloride) in breast cancer patients with brain metastases who progressed after radiation therapy. II. To estimate central nervous system (CNS) objective response and clinical benefit rate in patients with breast cancer and brain metastases treated with irinotecan. III. To estimate progression free survival. IV. To estimate overall survival. V. To assess the toxicity of Irinotecan. OUTLINE: Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 24 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Rita Mehta, MD

Affiliation: University of California, Irvine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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