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Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas

Cancer Type
Hematopoietic Malignancies
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
FEN T-14 (primary)
Study Sponsor
CerRx, Inc.


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.


  1. Adult patients > 18 years with histologically or cytologically confirmed Peripheral T-cell lymphoma (PTCL)
  2. 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.
  3. Patients with an ECOG performance status of 0, 1, or 2, and estimated survival of > 12 weeks.
  4. 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

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.