Clinical Trial: Cilengitide in Treating Patients With Acute Myeloid Leukemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Disease-free survival (DFS) [ Time Frame: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years ]

Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.


Original Primary Outcome:

Current Secondary Outcome:

  • Overall survival [ Time Frame: Up to 2 years ]
    Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
  • Toxicity of cilengitide graded using the CTC version 3 [ Time Frame: Up to 2 years ]
    Compared between the two treatment arms using Fisher's exact test


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 4, 2004
Date Started: July 2004
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013