This study addresses the hypothesis that intermittent treatment with fenretinide intravenous emulsion will induce objective responses in patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) who have failed at least one prior systemic therapy and will result in acceptable toxicities.
This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior system therapy. Approximately 140 patients will be enrolled. Patients will be treated with fenretinide (4-HPR) intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks until there is disease progression or unmanageable treatment-related toxicities. The primary study endpoint is objective response rate (ORR). Responses will be categorized using criteria established by the International Harmonization Project on Lymphoma. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to NCI-CTCAE v. 4.03.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGObjective response rate
Time frame: Objective tumor responses will be measured and recorded during the two weeks following the completion of the drug infusion of every even-numbered treatment cycle until the patient is removed from the study.
Safety and tolerability profile will be assessed by adverse events which will be graded according to NCI-CTCAE v. 4.03.
Time frame: monitored from start of initial therapy until 30 days after the patient is removed from study therapy.
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University of California, Los Angeles
Los Angeles, California, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGNorton Healthcare
Louisville, Kentucky, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGBon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States
RECRUITINGBaylor University Medical Center
Dallas, Texas, United States
RECRUITING...and 1 more locations