A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
cilengitide
Bone Marrow Diseases+13
+ Eosinophilia
+ Leukemia, Erythroblastic, Acute
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.70 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location