Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl) Retinamide, 4-HPR) Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL)
1 other identifier
interventional
140
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 23, 2019
July 1, 2019
4.6 years
July 7, 2015
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
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 Outcomes (1)
Safety and tolerability profile will be assessed by adverse events which will be graded according to NCI-CTCAE v. 4.03.
monitored from start of initial therapy until 30 days after the patient is removed from study therapy.
Study Arms (1)
Fenretinide emulsion
EXPERIMENTALPatients 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 intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CerRx, Inc.lead
Study Sites (11)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas, Southwestern
Dallas, Texas, 75390, United States
Related Publications (1)
Mohrbacher AM, Yang AS, Groshen S, Kummar S, Gutierrez ME, Kang MH, Tsao-Wei D, Reynolds CP, Newman EM, Maurer BJ. Phase I Study of Fenretinide Delivered Intravenously in Patients with Relapsed or Refractory Hematologic Malignancies: A California Cancer Consortium Trial. Clin Cancer Res. 2017 Aug 15;23(16):4550-4555. doi: 10.1158/1078-0432.CCR-17-0234. Epub 2017 Apr 18.
PMID: 28420721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kerry M. Barnhart, Ph.D.
CerRx, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 13, 2015
Study Start
December 1, 2016
Primary Completion
July 1, 2021
Study Completion
December 1, 2021
Last Updated
July 23, 2019
Record last verified: 2019-07