Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed.
|Sarcoma||Drug: carboplatin Drug: etoposide Drug: ifosfamide Procedure: hyperthermia treatment||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients|
|Study Start Date:||July 1996|
|Study Completion Date:||April 2003|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced sarcoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and ICE in these patients. IV. Obtain pilot data on the effect of WBH and ICE on cytokine induction in these patients.
OUTLINE: Treatment of whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) is given every 3-4 weeks. On day 1 of the treatment, ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia. Carboplatin is administered intravenously over 20 minutes while at the maximum temperature. Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia. Patient disease status is reevaluated after 2 courses. If there is no disease progression, treatment continues for a maximum of 4 courses.
PROJECTED ACCRUAL: Approximately 17-34 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002974
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||H. I. Robins, MD, PhD||University of Wisconsin, Madison|