Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062075
• Other study ID #: NCI-2009-00034
• Secondary ID: 12209BCDR0000304
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: December 3, 2015
• Start date: May 2003

Study information

• Verified date: April 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Promyelocytic, Acute
• Recurrent Adult Acute Myeloid Leukemia

Intervention

Drug:
• romidepsin
Given IV

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete and partial)		Up to 7 years	No
Primary	Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0		Up to 7 years	Yes