Cilengitide in Treating Patients With Acute Myeloid Leukemia

National Cancer Institute (NCI)

Status and phase

Terminated

Phase 2

Conditions

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Adult Acute Megakaryoblastic Leukemia (M7)

Adult Erythroleukemia (M6a)

Adult Acute Basophilic Leukemia

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Adult Pure Erythroid Leukemia (M6b)

Adult Acute Myeloid Leukemia in Remission

Adult Acute Monoblastic Leukemia (M5a)

Adult Acute Eosinophilic Leukemia

Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Adult Acute Minimally Differentiated Myeloid Leukemia (M0)

Adult Acute Monocytic Leukemia (M5b)

Treatments

Drug: cilengitide

Study type

Interventional

Funder types

NIH

Identifiers

NCT00089388

MDA-2003-1007

NCI-2012-02621

CDR0000378310 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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