Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00003060|
Recruitment Status : Unknown
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 25, 2003
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Official Title:||Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma|
|Study Start Date :||March 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003060
|United States, Louisiana|
|Louisiana State University School of Medicine|
|Shreveport, Louisiana, United States, 71130-3932|
|Study Chair:||Benjamin B. Weinberger, MD||Feist-Weiller Cancer Center at Louisiana State University Health Sciences|