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Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant Melanoma

Phase 2
16 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

Phase II Evaluation of IV Melphalan (L-PAM) and Whole Body Hyperthermia (WBH) for Malignant 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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced melanoma beyond hope of
surgical cure or metastatic disease Tumors must be refractory to all known forms of
effective therapy No CNS tumor involvement No major liver involvement (more than 33%
replacement of liver by tumor)

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC greater than 3,000/mm3 Absolute granulocyte count at
least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times
normal Protein no less than 15% below lower limit of normal Renal: BUN less than 30 mg/dL
Creatinine less than 1.5 mg/dL OR Creatinine clearance no less than 60 mL/min Calcium no
greater than 11.0 mg/dL Sodium 130-150 mEq/L Potassium 3.0-5.0 mg/dL Cardiovascular: No
organic heart disease, including: - coronary artery disease - history of angina - history
of dysrhythmia requiring ongoing medical intervention - uncontrolled hypertension -
patients requiring beta blockers Neurologic: No moderate or severe peripheral neuropathy
No history of severe emotional instability by psychiatric history Pulmonary: FEV1 at least
60% of predicted Maximum voluntary volume at least 60% of predicted Partial pressure of
oxygen at least 60 OR Oxygen saturation at least 90% Other: No history of secondary
primary cancer which conceivably could be active No active nonmalignant gastric and/or
duodenal ulcer No serious infection requiring hospitalization within the previous 14 days
No history of hepatitis related to general anesthesia No history of allergy to lidocaine
or related compounds No development of malignant hyperthermia after general anesthesia No
unexplained persistent fever Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biologic therapy
Chemotherapy: At least 8 weeks since nitrosoureas (e.g., lomustine, carmustine, mitomycin)
At least 4 weeks since any other chemotherapy Recovered from all toxic effects No
concurrent chemotherapy Endocrine therapy: At least 4 weeks since endocrine therapy No
concurrent hormonal therapy Radiotherapy: At least 4 weeks since radiotherapy No prior
irradiation of more than 25% of the marrow Surgery: Not specified Other: No concurrent
nonsteroidal antiinflammatory agents or aspirin

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

H. I. Robins, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

December 1995

Completion Date:

December 2000

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Fever
  • Melanoma



University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792