- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Louisiana
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Benjamin B. Weinberger, MD, Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Antifungal Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Calcineurin Inhibitors
- Cyclophosphamide
- Methotrexate
- Busulfan
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- LSU-95456
- CDR0000065722 (Registry Identifier: PDQ (Physician Data Query))
- NCI-V97-1318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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