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FR901228 in Treating Patients With Hematologic Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 13, 2001
Last updated: January 30, 2013
Last verified: November 2002

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.

Condition Intervention Phase
Drug: romidepsin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)

Resource links provided by NLM:

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

Study Start Date: January 2002
Study Completion Date: August 2006
Detailed Description:


  • Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia.
  • Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.
  • Determine any preliminary anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia).

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose.

PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of one of the following hematologic malignancies:

    • Chronic lymphocytic leukemia (CLL)
    • Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)
    • Acute myeloid leukemia (AML)
    • Acute lymphoblastic leukemia (ALL)
  • Stratum I (CLL and SLL):

    • Received at least one prior therapy containing a purine analog OR
    • Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy
  • Stratum II (AML and ALL):

    • Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy
    • OR
    • Untreated or previously treated poor-risk leukemia defined by any of the following:

      • 65 years of age and over
      • Poor-risk candidates for aggressive chemotherapy
      • Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Stratum I only:

    • No uncontrolled autoimmune hemolytic anemia
    • No idiopathic thrombocytopenic purpura
  • Stratum II only:

    • WBC no greater than 10,000/mm^3 OR
    • WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)


  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 3 times upper limit of normal


  • Creatinine less than 2.0 mg/dL


  • Ejection fraction at least 50% by MUGA
  • No myocardial infarction or unstable angina within the past 6 months
  • No prior unstable ventricular or supraventricular cardiac arrhythmias


  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other medical or psychiatric problem that would preclude study
  • Stratum I only:

    • No active infection requiring oral or IV antibiotics


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 28 days since prior chemotherapy (except hydroxyurea)
  • At least 6 weeks since prior nitrosoureas
  • At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)

Endocrine therapy:

  • See Disease Characteristics


  • At least 28 days since prior radiotherapy


  • At least 28 days since prior major surgery
  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 identifier: NCT00024180

United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Guido Marcucci, MD Ohio State University Comprehensive Cancer Center
  More Information

Publications: Identifier: NCT00024180     History of Changes
Other Study ID Numbers: CDR0000068898
Study First Received: September 13, 2001
Last Updated: January 30, 2013

Keywords provided by National Cancer Institute (NCI):
Waldenström macroglobulinemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
refractory chronic lymphocytic leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
recurrent small lymphocytic lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on April 28, 2017