Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

NCT ID: NCT00003060

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-03-31
• Study Completion Date: 2001-02-22

Brief 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)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

cyclosporine

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin B. Weinberger, MD

Role: STUDY_CHAIR

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Locations

Louisiana State University School of Medicine

Shreveport, Louisiana, United States

Countries

United States

Other Identifiers

CDR0000065722

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V97-1318

Identifier Type: -

Identifier Source: secondary_id

LSU-95456

Identifier Type: -

Identifier Source: org_study_id