A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients
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.
Interventional
Primary Purpose: Treatment
H. I. Robins, MD, PhD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
CDR0000065489
NCT00002974
July 1996
April 2003
Name | Location |
---|---|
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |