Cilengitide in Treating Patients With Acute Myeloid Leukemia

NCT ID: NCT00089388

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31

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.

Conditions

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (low dose cilengitide)

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

Group Type: EXPERIMENTAL

cilengitide

Intervention Type: DRUG

Given IV

Arm II (higher dose cilengitide)

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

Group Type: EXPERIMENTAL

cilengitide

Intervention Type: DRUG

Given IV

Interventions

cilengitide

Given IV

Intervention Type: DRUG

Other Intervention Names

EMD 121974

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srdan Verstovsek

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-2003-1007

Identifier Type: -

Identifier Source: secondary_id

CDR0000378310

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02621

Identifier Type: -

Identifier Source: org_study_id