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Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma - Article


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Bone Marrow/bone Marrow Transplantation

Bone Marrow Transplant; Bone Marrow Transplantation


Clinical Trial: Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

This study is no longer recruiting patients.

Sponsored by: Louisiana State University
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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--

--Prior/Concurrent Therapy--

--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

Study chairs or principal investigators

Benjamin Barry Weinberger,  Study Chair,  Louisiana State University   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065722; LSU-95456; NCI-V97-1318
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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October 12, 2008



Page Updated: October 1, 2005
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