Trials / Terminated

TerminatedNCT00089388

Cilengitide in Treating Patients With Acute Myeloid Leukemia

A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 70 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 50 Years
Healthy volunteers: Not accepted

Summary

This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth

Detailed description

PRIMARY OBJECTIVES: I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy. SECONDARY OBJECTIVES: I. Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks. Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks. In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity.

Conditions

Interventions

Type	Name	Description
DRUG	cilengitide	Given IV

Timeline

Start date: 2004-07-01
Primary completion: 2006-06-01
First posted: 2004-08-05
Last updated: 2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00089388. Inclusion in this directory is not an endorsement.