Spots Global Cancer Trial Database for Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
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Trial Identification
Brief Title: Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
Official Title: Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) Retinamide, 4-HPR) Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL)
Study ID: NCT02495415
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
Emory University, Atlanta, Georgia, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Norton Healthcare, Louisville, Kentucky, United States
University of Louisville, Louisville, Kentucky, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Bon Secours Saint Francis Cancer Center, Greenville, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas, Southwestern, Dallas, Texas, United States
Contact Details
Name: Kerry M. Barnhart, Ph.D.
Affiliation: CerRx, Inc.
Role: STUDY_DIRECTOR
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