Cilengitide in Treating Patients With Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00089388

Purpose

RATIONALE: Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cilengitide	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cilengitide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relapse-free survival as measured by complete remission at 10 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival assessed every 3 months [ Designated as safety issue: No ]
Safety and toxicity as measured by AdEERS reports, complete blood counts including differentials and platelet count, and blood chemistry every 2 weeks during the first course and then on day 1 of subsequent courses [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	October 2005

Detailed Description:

OBJECTIVES:

Primary

Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.

Secondary

Determine overall survival of patients treated with this drug.
Determine the safety and toxicity of this drug in these patients.
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.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 17.5-24 months.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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)

PATIENT CHARACTERISTICS:

Age

50 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

See Disease Characteristics

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 2.5 times ULN

Renal

Creatinine ≤ 1.5 times ULN OR
Creatinine clearance > 60mL/min

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior investigational agents specifically designated as an antiangiogenic agent
No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

See Disease Characteristics
Recovered from prior consolidation chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No other concurrent anticancer therapies
No other concurrent investigational cytotoxic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089388

Locations

United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, New York
Hematology Oncology Associates of Central New York, PC - East Syracuse
East Syracuse, New York, United States, 13057-4510
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Srdan Verstovsek, MD

M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000378310, MDA-2003-1007, NCI-6384
Study First Received:	August 4, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00089388
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult acute myeloid leukemia in remission
adult acute eosinophilic leukemia
adult acute basophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult erythroleukemia (M6a)
adult acute myeloblastic leukemia without maturation (M1)

adult acute monocytic leukemia (M5b)
adult acute monoblastic leukemia (M5a)
adult acute minimally differentiated myeloid leukemia (M0)
adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Acute myelogenous leukemia
Acute erythroblastic leukemia
Acute myeloid leukemia, adult

Leukemia, Myeloid
Di Guglielmo's syndrome
Congenital Abnormalities
Leukemia, Myeloid, Acute
Acute monoblastic leukemia
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009