Status:
COMPLETED
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 (de...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00077194
Start Date
January 1 2004
Last Update
February 11 2013
Active Locations (4)
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1
Howard University Cancer Center at Howard University Hospital
Washington D.C., District of Columbia, United States, 20060
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
3
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
4
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-5256