Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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 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

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