Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00002974
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1996-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-07
• Study Completion: 2003-04
• Study First Submitted QC: 2004-03-29
• Study First Posted: 2004-03-30
• Status Verified: 2011-05
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States