Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma |
| Estimated Enrollment: | 6 |
| Study Start Date: | 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.
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 to 44 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003060 History of Changes |
| Other Study ID Numbers: | CDR0000065722, LSU-95456, NCI-V97-1318 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Busulfan Cyclophosphamide Cyclosporins Cyclosporine Methotrexate Lenograstim Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Enzyme Inhibitors Antifungal Agents Anti-Infective Agents Dermatologic Agents Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on May 23, 2013