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Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma

Phase 1
16 Years
44 Years
Open (Enrolling)
Melanoma (Skin)

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Trial Information

Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma

OBJECTIVES: I. Determine the response rate and survival of patients with metastatic
malignant melanoma who have failed first-line therapy when treated with match-related
allogeneic bone marrow transplantation.

OUTLINE: This is a pilot study. Patients receive a preparative regimen of busulfan and
cyclophosphamide. Busulfan PO is administered every 6 hours on days -7 to -4.
Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest. Bone
marrow infusion occurs on day 0. Cyclosporine begins on day -1 and continues until day 180.
Methotrexate IV is administered on days 1, 3, 6, and 11. Granulocyte colony-stimulating
factor is administered as a continuous IV every 2 hours starting on day 12 and continuing
until absolute neutrophil count is greater than 1,000 g/dL for 2 consecutive days. Patients
receive weekly follow up for the first 180 days and monthly thereafter. Patients are
followed until death.

PROJECTED ACCRUAL: 6 patients with melanoma will be accrued.

Inclusion Criteria

DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior
standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor
(5- or 6-antigen match) No history of CNS metastases

PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times
upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL
AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac
disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1
greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO
greater than 50% predicted Other: Not pregnant Fertile women must use effective
contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B

PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Benjamin B. Weinberger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Feist-Weiller Cancer Center at Louisiana State University Health Sciences


United States: Federal Government

Study ID:




Start Date:

March 1995

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • Melanoma



Louisiana State University School of Medicine New Orleans, Louisiana  70112-2822