Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003552
Status:
TERMINATED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Melanoma
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2024-03
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 use different ways to stop tumor cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma
PURPOSE Phase III trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES I Identify an antitumor effect of allogeneic peripheral blood stem cell transplantation PBSCT in patients with metastatic melanoma
II Evaluate the safety and toxicity of a nonmyeloablative low intensity preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients
III Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in these patients
IV Investigate the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in this patient population
V Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient population
VI Determine disease-free survival overall survival and mortality from the procedure or tumor progression in this patient population
PROTOCOL OUTLINE This is a dose-escalation study of a conditioning regimen Patients receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell PBPC transplantation Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1 Patients at dose level 2 receive cyclophosphamide IV over 1 hour on days -7 and -6 fludarabine IV over 30 minutes daily on days -5 to -1 and antithymocyte globulin daily on days -5 to -2 Patients at dose level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6 fludarabine IV over 30 minutes daily on days -5 to -1 and antithymocyte globulin daily on days -5 to -2
Patients undergo mobilized CD34 PBPC transplantation on day 0 PBPC transplantation may be repeated on days 1 and 2 if deemed necessary
Patients with progressive disease on days 15-30 day 60 or day 100 without graft-versus-host disease receive infusions of donor lymphocytes Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician
Patients are followed every 2 months for 6 months every 3 months for the next 2 years and then every 6 months until year 5 posttransplantation
PROJECTED ACCRUAL
A total of 40 patients will be accrued for this study
II Evaluate the safety and toxicity of a nonmyeloablative low intensity preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients
III Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in these patients
IV Investigate the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in this patient population
V Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient population
VI Determine disease-free survival overall survival and mortality from the procedure or tumor progression in this patient population
PROTOCOL OUTLINE This is a dose-escalation study of a conditioning regimen Patients receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell PBPC transplantation Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1 Patients at dose level 2 receive cyclophosphamide IV over 1 hour on days -7 and -6 fludarabine IV over 30 minutes daily on days -5 to -1 and antithymocyte globulin daily on days -5 to -2 Patients at dose level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6 fludarabine IV over 30 minutes daily on days -5 to -1 and antithymocyte globulin daily on days -5 to -2
Patients undergo mobilized CD34 PBPC transplantation on day 0 PBPC transplantation may be repeated on days 1 and 2 if deemed necessary
Patients with progressive disease on days 15-30 day 60 or day 100 without graft-versus-host disease receive infusions of donor lymphocytes Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician
Patients are followed every 2 months for 6 months every 3 months for the next 2 years and then every 6 months until year 5 posttransplantation
PROJECTED ACCRUAL
A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| NHLBI-98-H-0006 | None | None | None |