MedTrace Logo

Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall

NCT00826085 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-01-30

No results posted yet for this study

Summary

This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.

Conditions

Interventions

DRUG

ThermoDox in combination with Microwave Hyperthermia (heat)

ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion. Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system. All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals.

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Nicholas Borys, MD · Imunon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00826085 on ClinicalTrials.gov