MRI Sarcoma Non Invasive Thermometry

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Using MRI to measure heat may help to determine the effectiveness of hyperthermia therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hyperthermia with radiation therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so that it can be removed.

PURPOSE: This phase I/II trial is studying the side effects of hyperthermia when given together with radiation therapy and optional chemotherapy and to see how well they work in treating patients who are undergoing surgery for soft tissue sarcoma of the limbs.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mark Dewhirst
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Mesna

Criteria

Inclusion Criteria:

• Patients will have histologically proven grade 2 or grade 3 soft tissue sarcoma.

• Karnofsky performance status ≥ 70.

• Life expectancy ≥ 6 months.

• There is no specific tumor size limitation, but the involved extremity must fit within the hyperthermia applicator.

• Patients must be ≥ 18 years of age.

• Patients who are to receive chemotherapy must have a left ventricular ejection fraction on resting MUGA scan of at least 45% to confirm adequate cardiac function

• Patients must competent to consent to be in the study and sign an approved informed consent.

Exclusion Criteria:

• Pregnant patients

• Patients with cardiac pacemakers and implanted defibrillators or other devices not compatible with ultrasound or microwave technology

• Patients who have any metal in their bodies including orthopedic rods, surgical clips, bullets, or shrapnel, etc. unless cleared by MRI staff and Hyperthermia physicians