Cilengitide in Treating Patients With Acute Myeloid Leukemia

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial

Official title:

A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00089388
• Other study ID #: NCI-2012-02621
• Secondary ID: MDA-2003-1007CDR
• Status: Terminated
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: January 23, 2013
• Start date: July 2004

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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)
• Hypereosinophilic Syndrome
• Leukemia
• Leukemia, Erythroblastic, Acute
• Leukemia, Megakaryoblastic, Acute
• Leukemia, Monocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• cilengitide
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall survival	Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.	Up to 2 years	No
Secondary	Toxicity of cilengitide graded using the CTC version 3	Compared between the two treatment arms using Fisher's exact test	Up to 2 years	Yes