Status:
TERMINATED
Cilengitide in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 necessar...
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 OBJECTI...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00089388
Start Date
July 1 2004
Last Update
January 24 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030