 |
|
Phase II Randomized Study of Cilengitide as Maintenance Therapy in Patients With Acute Myeloid Leukemia in First Complete Remission
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Cilengitide in Treating Patients With Acute Myeloid Leukemia
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase II
|
|
|
|
Treatment
|
|
|
|
Completed
|
|
|
|
50 and over
|
|
|
|
NCI
|
|
|
|
MDA-2003-1007
6384, NCI-6384, NCT00089388
|
|
|
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.
Entry 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/mm3
- Absolute neutrophil count > 1,500/mm3
- 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)
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 Radiotherapy Surgery Other - No other concurrent anticancer therapies
- No other concurrent investigational cytotoxic agents
Patient Characteristics:
Age Performance status - ECOG 0-2
OR - Karnofsky 60-100%
Life expectancy 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
Expected Enrollment 70A total of 70 patients (35 per treatment arm) will be accrued for this study within 17.5-24 months. Outcomes Primary Outcome(s)Relapse-free survival as measured by complete remission at 10 months
Secondary Outcome(s)Overall survival assessed every 3 months
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
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.
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas | | | | Srdan Verstovsek, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets with Acute Myeloid Leukemia in Complete Remission | | | Trial Start Date | | 2005-10-13 | | | Registered in ClinicalTrials.gov | | NCT00089388 | | | Date Submitted to PDQ | | 2004-07-08 | | | Information Last Verified | | 2006-06-12 | | | NCI Grant/Contract Number | | CA16672, CM17003 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
 |
