Sarcoma Clinical Trial
Official title:
A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients
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.
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.
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