search
Back to results

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

Primary Purpose

Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
romidepsin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adult Diffuse Large Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.

Outcomes

Primary Outcome Measures

Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
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.

Secondary Outcome Measures

Median Progression Free-survival (PFS)
Time to disease progression is defined as the time from registration to documentation of disease progression.
Median Overall Survival
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.

Full Information

First Posted
September 29, 2006
Last Updated
May 2, 2014
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00383565
Brief Title
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
romidepsin
Other Intervention Name(s)
FK228, FR901228, Istodax
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
Description
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.
Time Frame
24 weeks (6 courses of 4 week cycles)
Secondary Outcome Measure Information:
Title
Median Progression Free-survival (PFS)
Description
Time to disease progression is defined as the time from registration to documentation of disease progression.
Time Frame
2 Years
Title
Median Overall Survival
Description
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.
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Romaguera
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs