NCT00003060

Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Louisiana State University Health Sciences Center Shreveport · Academic / Other
• Sex: All
• Age: 16 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	methotrexate
PROCEDURE	allogeneic bone marrow transplantation

Timeline

• Start date: 1995-03-01
• Primary completion: 2001-02-22
• Completion: 2001-02-22
• First posted: 2003-11-25
• Last updated: 2020-06-30

Locations

1 site across 1 country: United States