Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
FEN T-14 (primary)
NCI-2015-01195
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.
Objectives
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.
Eligibility
- Adult patients > 18 years with histologically or cytologically confirmed Peripheral T-cell lymphoma (PTCL)
- Diseases refractory/relapsed after one or more systemic cytotoxic therapies; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Patients with an ECOG performance status of 0, 1, or 2, and estimated survival of > 12 weeks.
- Patients with at least ONE of the following sites of measurable disease according to International Workshop Criteria87: A) Measurable tumor on MRI or CT scan. Measurable is defined as at least one lesion 20 mm in at least one dimension; for spiral CT, measurable is defined as 10 mm in at least one dimension. For patients with persistent disease, a biopsy of bone marrow, or bone, or a soft tissue site, must have demonstrated viable tumor. If lesion was radiated, biopsy must have been done at least 4 weeks after radiation completed. B) Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate and/or biopsy on one bone marrow sample, except for patient who tested positive subsequent to their last treatment regimen or patients who had a negative marrow within three months of study entry.
Treatment Sites in Georgia
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