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

Sponsor
University of California, Irvine
Study ID
NCT01939483
Status
Withdrawn

Conditions

  • Central Nervous System Metastases
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 31, 2012
Status verified
Oct 2014
Primary completion
Aug 31, 2017
Completion
Aug 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan hydrochloride)
    Patients receive irinotecan hydrochloride 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. This arm also includes laboratory biomarker analysis as an intervention.

Primary Outcome Measure

CNS objective response (complete response or partial response), defined as at least 20% volumetric reduction of CNS lesions in absence of increasing steroid use, progressive neurologic signs and symptoms, or progressive extra-CNS disease, based on MRI [ Time Frame: Up to 24 months ]

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