Clinical Trials Directory

Trials / Completed

CompletedNCT00060372

Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

CTLA-4 Blockade With MDX-010 to Induce Graft-Versus-Malignancy Effects Following Allogeneic Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
21 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGipilimumabGiven IV
DRUGtherapeutic allogeneic lymphocytesGiven IV

Timeline

Start date
2003-04-01
Primary completion
2008-04-01
First posted
2003-05-07
Last updated
2013-03-27

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00060372. Inclusion in this directory is not an endorsement.