Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT00062075 | Completed Phase 2

• 7 other identifiers: NCI-2009-0003412209BCDR0000304460N01CM62201N01CM17102U01CA099177P30CA014599
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Response rate (complete and partial)

  Up to 7 years

• Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0

  Up to 7 years

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

romidepsin DRUG

Given IV

Also known as: FK228, FR901228, Istodax

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Leukemia, Promyelocytic, Acute; Leukemia, Myeloid, Acute

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Olatoyosi Odenike

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Primary Completion: March 1, 2007
• Last Updated: December 4, 2015

Record last verified: 2013-04

Locations

US (2)