FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Stopped early · Phase 2
Conditions studied: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00383565
- Run by
- National Cancer Institute (NCI)
- People needed
- 9
- Starts
- 2006-09-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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