Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060372
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2003-05-06
Brief Title:
Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
CTLA-4 Blockade With MDX-010 to Induce Graft-Versus-Malignancy Effects Following Allogeneic Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2013-03
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:
This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the dose of MDX-010 ipilimumab that can safely be administered to patients with persistent or progressive malignancy following allo-HCT
II To determine the pharmacokinetics of different doses of MDX-010 administered as a single dose to patients with persistent or progressive malignancy following allo-HCT
III By assessment of aims 1 and 2 to determine the best dosing regimen for further study of CTLA-4 blockade in conjunction with escalating dose donor-leukocyte infusions DLI in patients with evidence of residual or progressive malignancy following allo-HCT
IV To assess if there is preliminary evidence of efficacy following the administration of MDX-010 in this population
OUTLINE
Patients receive ipilimumab intravenously IV over 90 minutes
Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose MTD is determined The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions
Patients are followed at 4 5 6 9 and 12 months and then annually thereafter
I To determine the dose of MDX-010 ipilimumab that can safely be administered to patients with persistent or progressive malignancy following allo-HCT
II To determine the pharmacokinetics of different doses of MDX-010 administered as a single dose to patients with persistent or progressive malignancy following allo-HCT
III By assessment of aims 1 and 2 to determine the best dosing regimen for further study of CTLA-4 blockade in conjunction with escalating dose donor-leukocyte infusions DLI in patients with evidence of residual or progressive malignancy following allo-HCT
IV To assess if there is preliminary evidence of efficacy following the administration of MDX-010 in this population
OUTLINE
Patients receive ipilimumab intravenously IV over 90 minutes
Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose MTD is determined The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions
Patients are followed at 4 5 6 9 and 12 months and then annually thereafter
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 |
|---|---|---|---|
| R01CA093891 | NIH | None | httpsreporternihgovquickSearchR01CA093891 |
| 040749 | None | None | None |
| P-6082 | None | None | None |
| NCI-6082 | None | None | None |
| CDR0000301644 | None | None | None |