Cilengitide in Treating Patients With Acute Myeloid Leukemia

Phase 2

Terminated

• 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)
• Interventions: Drug: cilengitide

• Registration Number: NCT00089388
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Primary Completion: 2006-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (low dose cilengitide)	cilengitide	Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II (higher dose cilengitide)	cilengitide	Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States