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Biotech / Medical : Indications -- Cancer
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To: scaram(o)uche who wrote (351)5/8/2003 2:24:17 AM
From: Icebrg  Read Replies (1) of 1840
 
Rick

What's your opinion on this one? To me it looks like a very aggressive strategy. Will it work?

Erik

Official Title: Phase I Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Persistent or Progressive Malignancies

Further Study Details:

OBJECTIVES:

* Determine the optimal safe dose, in terms of incidence of grade 3 or 4 graft-versus-host disease, of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody administered to patients with persistent or progressive malignancies after allogeneic hematopoietic stem cell transplantation (AHSCT).
* Determine the pharmacokinetics of this drug in these patients.
* Determine the best dosing regimen of this drug when administered with donor lymphocyte infusions in these patients.
* Determine, preliminarily, the efficacy of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Between days 100-370 after allogeneic hematopoietic stem cell transplantation, patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes.

Cohorts of 3-6 patients receive escalating doses of MDX-010 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 MDX-010 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 6, 9, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 24-30 months.
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