Melanoma (Skin) Clinical Trial
Official title:
Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant 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.
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.
;
Primary Purpose: Treatment
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