Brief Title
Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML
Brief Summary
This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228 (depsipeptide). II. Determine the toxicity of this drug in these patients. III. Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug. OUTLINE: Patients are stratified according to the presence of a specific chromosomal abnormality (t[8;21] vs inv 16 vs t[15;17] vs absence of these chromosomal abnormalities). Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate (complete and partial)
Condition
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Intervention
romidepsin
Study Arms / Comparison Groups
Treatment
Description: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
47
Start Date
May 2003
Primary Completion Date
March 2007
Eligibility Criteria
Inclusion Criteria: - Histologically confirmed acute myeloid leukemia (AML) defined by the WHO classification - Initial diagnosis with either of the following: - Bone marrow or peripheral blood myeloblasts of at least 20%, - Recurring genetic abnormalities (e.g., t[8;21], inv 16, or t[16;16]) and - Bone marrow blast percentage less than 20% - Relapsed or refractory disease defined by 1 of the following: - Under 60 years of age and in second relapse or greater, - Over 60 years of age and in first relapse, - Acute promyelocytic leukemia that has relapsed despite prior tretinoin and arsenic therapy, - Primary refractory AML for which no standard therapy exists - Patients who are over 60 years of age with previously untreated disease and who refuse conventional chemotherapy are eligible - Patients who are over 60 years of age and in first relapse and poor medical candidates for reinduction chemotherapy or who refuse conventional chemotherapy are eligible - Not medically appropriate for OR refused curative bone marrow or stem cell transplantation - No CNS leukemia - ECOG 0-2 OR Karnofsky 60-100% - LVEF at least 40% by MUGA - QTc interval less than 500 msec by EKG - No myocardial infarction within the past 3 months - 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 prior allergic reactions attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide) - No concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - No ongoing or active infection - At least 4 weeks since prior autologous stem cell or bone marrow transplantation - No prior allogeneic stem cell or bone marrow transplantation - No concurrent biologic agents - At least 2 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) - No concurrent chemotherapy, concurrent hydroxyurea allowed during the first course of study therapy to control hyperleukocytosis - No concurrent radiotherapy - Recovered from prior therapy - At least 4 weeks since prior investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate) - No other concurrent antineoplastic agents - No prior FR901228 (depsipeptide) - At least 2 weeks since prior radiotherapy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Olatoyosi Odenike, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00062075
Organization ID
NCI-2009-00034
Secondary IDs
12209B
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Olatoyosi Odenike, Principal Investigator, University of Chicago Comprehensive Cancer Center
Verification Date
April 2013