Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006233
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2000-09-11
Brief Title:
Combination Chemotherapy Total-Body Irradiation Peripheral Stem Cell Transplantation and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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
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
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with metastatic melanoma treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine and total body irradiation followed by cyclosporine and mycophenolate mofetil followed by donor lymphocyte infusion
Determine the disease-free and overall survival of patients treated with this regimen
Determine the toxicity of this nonmyeloablative conditioning regimen in these patients
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
Determine the objective response rate in patients with metastatic melanoma treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine and total body irradiation followed by cyclosporine and mycophenolate mofetil followed by donor lymphocyte infusion
Determine the disease-free and overall survival of patients treated with this regimen
Determine the toxicity of this nonmyeloablative conditioning regimen in these patients
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-146200 | None | None | None |
| NCI-G00-1841 | None | None | None |
| CDR0000068157 | REGISTRY | PDQ | None |