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

Primary Purpose

Lymphoma

Status
Completed
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 Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma, recurrent mantle cell lymphoma, recurrent adult Burkitt lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Hematopoietic 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) Hepatic Bilirubin ≤ upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST ≤ 2 times ULN Renal Creatinine ≤ ULN Cardiovascular 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 Pulmonary No chronic obstructive pulmonary disease Other 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 CONCURRENT THERAPY: Chemotherapy 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) Other 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

Sites / Locations

  • Howard University Cancer Center at Howard University Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Barbara Ann Karmanos Cancer Institute
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 10, 2004
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077194
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
February 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult diffuse large cell lymphoma, recurrent mantle cell lymphoma, recurrent adult Burkitt 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
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
romidepsin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Hematopoietic 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) Hepatic Bilirubin ≤ upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST ≤ 2 times ULN Renal Creatinine ≤ ULN Cardiovascular 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 Pulmonary No chronic obstructive pulmonary disease Other 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 CONCURRENT THERAPY: Chemotherapy 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) Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L. Bartlett, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Howard University Cancer Center at Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5256
Country
United States

12. IPD Sharing Statement

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

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