Cilengitide in Treating Patients With Acute Myeloid Leukemia

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00089388

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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

Condition or Disease	Intervention/Treatment	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

Detailed Description

PRIMARY OBJECTIVES:

Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.

SECONDARY OBJECTIVES:

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Jun 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [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.

Secondary Outcome Measures

Overall survival [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 [Up to 2 years]
Compared between the two treatment arms using Fisher's exact test

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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