Clinical trial NCT00089388: Cilengitide in Treating Patients With Acute Myeloid Leukemia
Official title: A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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)
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-05
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 necessary for their growth

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 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.

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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years
measure: Toxicity of cilengitide graded using the CTC version 3
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Srdan Verstovsek
role: PRINCIPAL_INVESTIGATOR
References: