Cilengitide in Treating Patients With Acute Myeloid Leukemia

Stopped early · Phase 2

Conditions studied: 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)

In brief

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

Key facts

Study ID

NCT00089388

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2004-07-01

Last updated by the study team

2013-01-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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