NCT00089388

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

August 4, 2004

Last Update Submit

January 23, 2013

Conditions

Adult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult 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 RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    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 Outcomes (2)

  • Overall survival

    Up to 2 years

  • Toxicity of cilengitide graded using the CTC version 3

    Up to 2 years

Study Arms (2)

Arm I (low dose cilengitide)

EXPERIMENTAL

Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.

Drug: cilengitide

Arm II (higher dose cilengitide)

EXPERIMENTAL

Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.

Drug: cilengitide

Interventions

cilengitideDRUG

Given IV

Also known as: EMD 121974
Arm I (low dose cilengitide)Arm II (higher dose cilengitide)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Erythroblastic, Acute

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyeloproliferative DisordersBone Marrow Diseases

Study Officials

  • Srdan Verstovsek

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

July 1, 2004

Primary Completion

June 1, 2006

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)