Cilengitide in Treating Patients With Acute Myeloid Leukemia

January 23, 2013 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia (AML)

  • In first complete remission after at least 1 course of induction chemotherapy AND 1-2 courses of consolidation chemotherapy for newly diagnosed AML, as defined by the following:

    • No evidence of disease in bone marrow

    • Recovery of peripheral blood counts

      • Platelet count > 100,000/mm^3
      • Absolute neutrophil count > 1,500/mm^3
  • Must be able to start study medication within 60 days from the start of the last consolidation therapy
  • Must not have a suitable donor, refused, or ineligible for hematopoietic stem call transplantation

  • None of the following AML subtypes or chromosomal translocations:

    • Acute promyelocytic leukemia
    • t(8;21)
    • t(16;16)
    • inv(16)
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • See Disease Characteristics
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 60mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No prior investigational agents specifically designated as an antiangiogenic agent
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • See Disease Characteristics
  • Recovered from prior consolidation chemotherapy
  • No other concurrent anticancer therapies
  • No other concurrent investigational cytotoxic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I (low dose cilengitide)
Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Drug: cilengitide
Given IV
Other Names:
  • EMD 121974
EXPERIMENTAL: Arm II (higher dose cilengitide)
Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
Drug: cilengitide
Given IV
Other Names:
  • EMD 121974

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 2 years
Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
Up to 2 years
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
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

August 4, 2004

First Submitted That Met QC Criteria

August 4, 2004

First Posted (ESTIMATE)

August 5, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02621
  • MDA-2003-1007
  • CDR0000378310 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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