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Clinical Trial: Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
This study is no longer recruiting patients.
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Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Recurrent Melanoma | Procedure: chemotherapy Procedure: biological response modifier therapy Procedure: allogeneic bone marrow transplantation Procedure: graft versus host disease prophylaxis/therapy Procedure: bone marrow transplantation Behavior: supportive care/therapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Drug: bone marrow ablation with stem cell support Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: methotrexate | Phase I |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study of Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma
Study start: March 1995
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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 16 Years - 44 Years
Criteria
PROTOCOL ENTRY 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
--Prior/Concurrent Therapy--
- At least 1 prior standard regimen for metastatic disease
--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
Location Information
Louisiana
Louisiana State University School of Medicine, Shreveport, Louisiana, 71130-3932, United States
Benjamin Barry Weinberger, Study Chair, Louisiana State University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003060
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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