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Cilengitide in Treating Patients With Acute Myeloid Leukemia

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00089388
First received: August 4, 2004
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
 Drug: cilengitide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Compared between the two treatment arms using Fisher's exact test


Enrollment: 70
Study Start Date: July 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EMD 121974

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089388

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Srdan Verstovsek M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00089388     History of Changes
Other Study ID Numbers: NCI-2012-02621, MDA-2003-1007, CDR0000378310
Study First Received: August 4, 2004
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Leukemia
Leukemia, Basophilic, Acute
Leukemia, Eosinophilic, Acute
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid, Acute
Leukemia, Myeloid
 Hypereosinophilic Syndrome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Eosinophilia
Leukocyte Disorders

ClinicalTrials.gov processed this record on June 18, 2013