MedTrace Logo

Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer

NCT00346229 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-03-22

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

pegfilgrastim

DRUG

lyso-thermosensitive liposomal doxorubicin(Thermodox)

PROCEDURE

hyperthermia treatment

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Kimberly L. Blackwell, MD · Duke Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00346229 on ClinicalTrials.gov