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

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ClinicalTrials.gov Identifier: NCT00383565
Recruitment Status : Terminated
First Posted : October 3, 2006
Results First Posted : August 22, 2012
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 29, 2006
First Posted Date  ICMJE October 3, 2006
Results First Submitted Date  ICMJE July 19, 2012
Results First Posted Date  ICMJE August 22, 2012
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment [ Time Frame: 24 weeks (6 courses of 4 week cycles) ]
International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00383565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Median Progression Free-survival (PFS) [ Time Frame: 2 Years ]
    Time to disease progression is defined as the time from registration to documentation of disease progression.
  • Median Overall Survival [ Time Frame: 5 Years ]
    Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Study of Depsipeptide, a Histone Deacetylase Inhibitor, in Relapsed or Refractory Mantle Cell or Diffuse Large Cell Non-Hodgkin's Lymphoma
Brief Summary FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell to grow and by blocking blood flow to the cancer. This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Detailed Description

OBJECTIVES:

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

II. Evaluate the safety and feasibility of FR901228, in terms of the incidence of toxicity and maximum grade observed and courses delayed or dose reductions, in these patients.

III. Determine 2-year progression-free and overall survival.

OUTLINE: Patients receive FR901228 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.

After completion of study treatment, patients are followed every 3-6 months for up to 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
Intervention  ICMJE Drug: romidepsin
Given IV
Other Names:
  • FK228
  • FR901228
  • Istodax
Study Arms  ICMJE Experimental: Arm I
Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.
Intervention: Drug: romidepsin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2013)
9
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

    • Mantle cell lymphoma
    • Diffuse large cell lymphoma
    • (Ineligible for or unwilling to undergo stem cell transplantation)
  • Relapsed or refractory disease:

    • Any number of prior therapies allowed for relapsed disease, including peripheral blood stem cell or bone marrow transplantation
    • No more than 2 prior regimens, excluding monotherapy with monoclonal antibody or radiotherapy, for refractory disease
  • Measurable disease, defined as >= 1 lesion >= 1.5 cm in the longest diameter
  • No transformed lymphoma, defined as the transformation of a low-grade lymphoma, including follicular lymphoma or small lymphocytic lymphoma, to a high-grade lymphoma (e.g., diffuse large cell lymphoma)
  • ECOG performance status 0-2
  • Absolute neutrophil count >= 1,000/mm^3 OR >= 500/mm^3 if extensive bone marrow involvement (> 50%) or hypersplenism with palpable splenomegaly
  • Platelet count >= 75,000/mm^3 OR >= 50,000/mm^3 if extensive bone marrow involvement (> 50%) or hypersplenism with palpable splenomegaly
  • Bilirubin normal
  • Alkaline phosphatase =< 2 times upper limit of normal (ULN)
  • AST =< 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant cardiac disease, including New York Heart Association class III-IV congestive heart failure
  • No history of serious ventricular arrhythmia
  • QTc < 500 msec
  • No evidence of cardiac hypertrophy on ECG
  • No known HIV positivity
  • No other uncontrolled serious medical condition or active infection (e.g., chronic obstructive pulmonary disease, diabetes)
  • Recovered from prior therapy
  • No prior doxorubicin hydrochloride >= 450 mg/m^2 or mitoxantrone >= 112 mg/m^2 (Patients who received both mitoxantrone and doxorubicin hydrochloride should have a "doxorubicin equivalent dose" < 450 mg/m^2
  • No prior therapy with a histone deacetylase inhibitor
  • No concurrent dexamethasone or prednisone except for refractory nausea/vomiting
  • No concurrent drugs associated with QTc prolongation (e.g., dolasetron mesylate)
  • Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is receiving potassium chloride supplementation (No supplementation needed if switched to a potassium-conserving diuretic)
  • No CNS lymphoma
  • Creatinine normal
  • Cardiac function >= 50% by MUGA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383565
Other Study ID Numbers  ICMJE NCI-2009-00240
NCI-2009-00240 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2005-0579
CDR0000486326
2005-0579 ( Other Identifier: M D Anderson Cancer Center )
7869 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Romaguera M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP