Melphalan and Whole-Body Hyperthermia in Treating Patients With Advanced Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia in treating patients with advanced melanoma.
|Melanoma (Skin)||Drug: melphalan Procedure: hyperthermia treatment||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant Melanoma|
|Study Start Date:||December 1995|
|Study Completion Date:||December 2000|
|Primary Completion Date:||May 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and melphalan (L-PAM) in patients with advanced melanoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and L-PAM in these patients. IV. Obtain pilot data on the effect of WBH and L-PAM on cytokine induction in these patients.
OUTLINE: The combination of whole body hyperthermia (WBH) and melphalan (L-PAM) is administered on week 1. The infusion of L-PAM is administered at a constant rate over approximately 10 minutes, beginning 20 minutes after achieving target temperature of 41.8 degrees Celsius by esophageal or axillary temperature probe. WBH is continued for an additional 40 minutes for a total of 60 minutes. On week 5 or 6, patients receive another combination of WBH and L-PAM. Disease status is reevaluated at least every 2 courses. Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a maximum of 6 courses.
PROJECTED ACCRUAL: Approximately 34 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002973
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||H. I. Robins, MD, PhD||University of Wisconsin, Madison|