Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma
16 Years
44 Years
Both
Melanoma (Skin)
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
negative
PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000065722
NCT ID:
NCT00003060
Start Date:
March 1995
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
