Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062075
First received: June 5, 2003
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Drug: romidepsin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate (complete and partial) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 47
Study Start Date: May 2003
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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.
Drug: romidepsin
Given IV
Other Names:
  • FK228
  • FR901228
  • Istodax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062075

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Investigators
Principal Investigator: Olatoyosi Odenike University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062075     History of Changes
Other Study ID Numbers: NCI-2009-00034, 12209B, CDR0000304460, N01CM62201, N01CM17102, U01CA099177, P30CA014599
Study First Received: June 5, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014