This pilot clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with urinary tract cancer, gynecologic cancer, or head and neck cancer. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00911079.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility, defined as being able to administer hyperthermia at a specified temperature range and thermal dose within the defined time duration, of delivering catheter-based ultrasound hyperthermia following brachytherapy for treatment of tumor sites treated with brachytherapy.
II. To evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy.
SECONDARY OBJECTIVES:
I. To characterize the interstitial and endocavitary ultrasound heating technology by describing the thermal parameters including attainable temperature and thermal dose distribution and duration at the tumor treatment region.
OUTLINE:
Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.
After completion of study therapy, patients are followed at 1 and 3 months.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorI-Chow Joe Hsu
