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FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077194
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: romidepsin Phase 2

Detailed Description:


I. Determine the response rate (complete and partial) in patients with relapsed or refractory Burkitt's, mantle cell or diffuse large cell non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).

II. Determine the safety and feasibility of this drug, in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced, in these patients.

III. Determine the 2-year progression-free survival and overall survival of patients treated with this drug.

IV. Correlate tumor expression of BCL-2, BCL-6, BAX, and RAS with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma
Study Start Date : January 2004
Actual Primary Completion Date : December 2005

Arm Intervention/treatment
Experimental: Arm I
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: romidepsin

Information from the National Library of Medicine

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


  • Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types:

    • Diffuse large cell
    • Mantle cell
    • Burkitt's
  • Relapsed or refractory disease

    • No more than 2 prior regimen for patients with refractory disease
    • Any number of prior therapies (including peripheral blood stem cell or bone marrow transplantation) allowed for patients with relapsed disease provided there was an objective response to the most recent therapy
  • Measurable disease

    • At least 1 lesion ≥ 1.5 cm in diameter
  • No transformed lymphoma
  • No CNS lymphoma
  • Ineligible for, refused, or relapsed after stem cell transplantation



  • 18 and over

Performance status

  • ECOG 0-2


  • Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 in patients with extensive bone marrow involvement [> 50%] or hypersplenism with palpable splenomegaly)
  • Platelet count ≥ 75,000/mm^3 (50,000/mm^3 in patients with extensive bone marrow involvement or hypersplenism with palpable splenomegaly)


  • Bilirubin ≤ upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST ≤ 2 times ULN


  • Creatinine ≤ ULN


  • QTc < 500 msec by ECG
  • Cardiac function ≥ 50% by MUGA
  • No prior serious ventricular arrhythmia
  • No New York Heart Association class III or IV congestive heart failure
  • No significant cardiac hypertrophy by ECG
  • No other significant cardiac disease


  • No chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No diabetes
  • No other uncontrolled serious medical condition



  • Prior cumulative doxorubicin dose < 450 mg/m^2
  • Prior cumulative mitoxantrone dose < 112 mg/m^2
  • Prior doxorubicin equivalent dose < 450 mg/m^2 (for patients who have previously received both doxorubicin and mitoxantrone)


  • Recovered from all prior therapy
  • No prior histone deacetylase inhibitor therapy
  • No concurrent medication associated with QTc prolongation, such as dolasetron
  • Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is on concurrent potassium chloride supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077194

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United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-5256
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Nancy L. Bartlett, MD Washington University Siteman Cancer Center

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00077194    
Other Study ID Numbers: NCI-2012-02571
CDR0000349660 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2005
Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent mantle cell lymphoma
recurrent adult Burkitt lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents