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Trial record 1 of 1 for:    FEN-T14
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Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by CerRx, Inc.
Sponsor:
Information provided by (Responsible Party):
CerRx, Inc.
ClinicalTrials.gov Identifier:
NCT02495415
First received: July 7, 2015
Last updated: April 29, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Peripheral T-cell Lymphoma Drug: Fenretinide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by CerRx, Inc.:

Primary Outcome Measures:
  • Objective 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. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 140
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenretinide emulsion
Patients enrolled will receive 600 mg fenretinide/m2/day on Day 1, followed by 1200 mg fenretinide/m2/day on Days 2 - 5 as a continuous intravenous infusion via central line over 5 days. Cycles are repeated every 3 weeks.
Drug: Fenretinide
Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.
Other Names:
  • 4-HPR
  • (N-(4-hydroxyphenyl) retinamide

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unable to give written informed consent
  • Patients who have received chemotherapy within 3 weeks of first fenretinide treatment, or who have received investigational drugs within 6 weeks of first fenretinide treatment. Patients must have otherwise recovered from toxicities of prior therapy.
  • Patient is not eligible if radiation was given to the only site of measurable disease unless there has been subsequent disease progression at that site, or a biopsy of that site showed viable tumor at least 4 weeks after radiation was completed. Patients must not have received small field (focal) radiation for a minimum of 2 weeks prior to study entry. A minimum of 6 weeks is required following prior large field radiation therapy (i.e. TBI, craniospinal therapy, whole abdomen, total lung, > 50% marrow space)
  • Patients who have uncontrolled systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems.
  • Patients with any active hepatitis infections.
  • Growth factor(s): Must not have received any hematopoetic growth factors within 7 days of study entry.
  • Organ Transplant: Patients may NOT be the recipients of an organ transplant.
  • Women who are pregnant and/or lactating.
  • Patients who have had major non-biopsy surgery in the last 20 days.
  • CNS lesions: A) Patients with CNS parenchymal or meningeal-based lesions that are present at study entry are NOT eligible due to concerns regarding toxicity attribution. B) Who have active CNS disease or a history of cranial irradiation are excluded due to concerns regarding toxicity attribution. Patients with previously treated leptomeningeal disease or brain metastases without evidence of remaining tumor by PET, MRI scan, or spinal fluid will be eligible; however such patients currently taking steroids as prophylaxis against seizures are not eligible.
  • Patients with documented allergy to egg products.
  • Known history of, or positive test result for human immunodeficiency virus (HIV) infection.
  • Patients with fasting serum triglycerides > 300 and/or with hypertriglyceridemia requiring medication (but not patients with hypercholesterolemia: patients with hypercholesterolemia with or without medication are eligible).
  • Patients concurrently taking the following drugs are excluded: antioxidants, herbal or other alternative therapy medications, vitamin supplements (especially vitamins A, C, and E) other than at standard multivitamin doses, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, and amiodarone. If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study (screening visit) one week or 5-half lives of the drug in question, whichever is the longer, after the discontinuation. For patients requiring any of these medications, entry is permissible only with permission from the medical monitor.
  • Patients with poorly controlled diabetes mellitus with fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.
  • Patients with any known significant cardiac abnormality.
  • Patients with uncontrolled hypertension.
  • Participation in any other investigational treatment within the 6 weeks prior to enrollment or concurrent with this study.
  • Patients with an identified familial hyperlipidemia disorder.
  • Patients with documented allergy to soy products.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02495415

Contacts
Contact: Kerry M. Barnhart, Ph.D. kerry.barnhart@cerrx.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Donna Bui    626-218-1987    dbui@coh.org   
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Rachel Spencer    323-865-0579    spencer1@med.usc.edu   
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Robin Kemball    310-825-8195    rkemball@mednet.ucla.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Amanda Hutchison-Rzepka    404-778-3935    ahutch7@emory.edu   
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Radtke    502-899-3366 ext 111    susan.radtke@nortonhealthcare.org   
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Teresa Roberts    502-562-4006    tlrobe14@exchange.louisville.edu   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lauren Pascual    551-996-3129    lauren.pascual@hackensackmeridian.org   
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Felicia Kiplinger    405-271-8777    felicia-kiplinger@ouhsc.edu   
United States, Pennsylvania
Penn State University Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Stepanie Wachter    717-531-7417    swachter1@hmc.psu.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Shanta Salzer    843-792-1463    salzers@musc.edu   
Bon Secours Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Gretchen Reid    864-603-6218    Gretchen_Reid@bshsi.org   
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Sandy Li, RN    214-820-1530    sandy.li@bswhealth.org   
University of Texas, Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: ChiYon Carroll    214-648-6637    chiyon.carroll@utsouthwestern.edu   
Sponsors and Collaborators
CerRx, Inc.
Investigators
Study Director: Kerry M. Barnhart, Ph.D. CerRx, Inc.
  More Information

Responsible Party: CerRx, Inc.
ClinicalTrials.gov Identifier: NCT02495415     History of Changes
Other Study ID Numbers: FEN T-14
Study First Received: July 7, 2015
Last Updated: April 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Retinamide
Fenretinide
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017