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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006233 |
Purpose
RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation, peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion in Selected Patients With Metastatic Melanoma |
| Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation on day 0. Allogeneic peripheral blood stem cells are infused on day 0.
Patients receive oral cyclosporine twice a day on days -3 to 35 and tapered until day 56 and oral mycophenolate mofetil 3 times a day on days 0-40.
Patients with mixed chimerism and no graft-versus-host disease on day 56 receive donor lymphocyte infusion (DLI) over 30 minutes on day 65 unless there is evidence of increasing donor chimerism. DLI may be repeated every 65 days for up to 4 doses.
Patients are followed weekly for 3 months, monthly for 6 months, every 6 months through year 2, and then annually through year 5.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
HLA genotypically identical sibling donor available
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1023 | |
| Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
More Information
| Study ID Numbers: | CDR0000068157, FHCRC-1462.00, NCI-G00-1841 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006233 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Antimetabolites Cyclosporine Immunologic Factors Clotrimazole Miconazole Tioconazole Mycophenolic Acid Fludarabine monophosphate Immunosuppressive Agents Cyclosporins Recurrence Melanoma |
Neuroendocrine Tumors Anti-Bacterial Agents Neuroectodermal Tumors Antifungal Agents Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Mycophenolate mofetil Neuroepithelioma Nevus Fludarabine Antirheumatic Agents |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Mycophenolic Acid Antibiotics, Antineoplastic Cyclosporins Melanoma Neoplasms, Germ Cell and Embryonal Antifungal Agents |
Therapeutic Uses Mycophenolate mofetil Nevi and Melanomas Dermatologic Agents Neoplasms by Histologic Type Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Fludarabine Antirheumatic Agents |
