Stage IV Breast Cancer Clinical Trial
Official title:
CTLA-4 Blockade With MDX-010 to Induce Graft-Versus-Malignancy Effects Following Allogeneic Hematopoietic Stem Cell Transplantation
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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