Recruiting
Phase 2

Fenretinide

Sponsor:

CerRx, Inc.

Code:

NCT02495415

Conditions

Peripheral T-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fenretinide

Study Details

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.

Conditions

Peripheral T-cell Lymphoma

Study ID

NCT02495415

Start date

Dec, 2016

Status verified date

Jul, 2019

Completion date

Dec, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Fenretinide

Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Kerry M. Barnhart, Ph.D.

kerry.barnhart@cerrx.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Shelby Burlew

480-256-5414shelby.burlew@bannerhealth.com

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Christine Duran

323-865-0371duran_c@med.usc.edu

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Bessie Bautista

310-570-1457BBautista@mednet.ucla.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

David Reagan

404-778-3255david.j.reagan@emory.edu

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Sara Pearson

913-588-8292spearson@kumc.edu

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Dana Haycraft

502-899-3366dana.haycraft@nortonhealthcare.org

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Teresa Roberts

502-562-4006tlrobe14@exchange.louisville.edu

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Lauren Pascual

551-996-3129lauren.pascual@hackensackmeridian.org

Bon Secours Saint Francis Cancer Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Gretchen Reid

864-603-6218Gretchen_Reid@bshsi.org

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Sandy Li, RN

214-820-1530sandy.li@bswhealth.org

University of Texas, Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Donglan Xia

214-648-6637Donglan.Xia@utsouthwestern.edu

More Information

Sponsor

CerRx, Inc.

Last update posted

Jul 23, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CerRx, Inc. on 2019-07-23.