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Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Primary Purpose

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
romidepsin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm 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.

Outcomes

Primary Outcome Measures

Response rate (complete and partial)
Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
December 3, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062075
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
romidepsin
Other Intervention Name(s)
FK228, FR901228, Istodax
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response rate (complete and partial)
Time Frame
Up to 7 years
Title
Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olatoyosi Odenike
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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