Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer

NCT00765765 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-08-09

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help ixabepilone work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone given together with hydroxychloroquine and to see how well they work in treating patients with metastatic breast cancer.

Conditions

Interventions

DRUG

hydroxychloroquine

Dose escalation from 200 mg po qd to 200 mg po bid.

DRUG

ixabepilone

Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Vassil Karantza-Wadsworth, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00765765 on ClinicalTrials.gov