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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

June 30, 2016

Conditions
Breast Cancer
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."

Trial Locations (6)

19124

Eastern Regional Medical Center, Philadelphia

21201

University of Maryland, Baltimore

30265

Southeastern Regional Medical Center, Newnan

63110

Washington University in St. Louis, St Louis

74133

Southwestern Regional Medical Center, Tulsa

94143

University of California, San Francisco, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Imunon

INDUSTRY

NCT00826085 - Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall | Biotech Hunter | Biotech Hunter