Status:
TERMINATED
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
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 safet...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00383565
Start Date
September 1 2006
End Date
April 1 2011
Last Update
May 20 2014
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030