Cilengitide in Treating Patients With Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)
About this trial
This is an interventional treatment trial for Adult Acute Basophilic Leukemia
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (low dose cilengitide)
Arm II (higher dose cilengitide)
Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.