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Cilengitide in Treating Patients With Acute Myeloid Leukemia

Primary Purpose

Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cilengitide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Basophilic Leukemia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (low dose cilengitide)

Arm II (higher dose cilengitide)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
Toxicity of cilengitide graded using the CTC version 3
Compared between the two treatment arms using Fisher's exact test

Full Information

First Posted
August 4, 2004
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089388
Brief Title
Cilengitide in Treating Patients With Acute Myeloid Leukemia
Official Title
A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (low dose cilengitide)
Arm Type
Experimental
Arm Description
Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm Title
Arm II (higher dose cilengitide)
Arm Type
Experimental
Arm Description
Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
cilengitide
Other Intervention Name(s)
EMD 121974
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
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.
Time Frame
From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
Time Frame
Up to 2 years
Title
Toxicity of cilengitide graded using the CTC version 3
Description
Compared between the two treatment arms using Fisher's exact test
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srdan Verstovsek
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Cilengitide in Treating Patients With Acute Myeloid Leukemia

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