Peripheral T-cell LymphomaPhase 2NCT02495415
Trial of Intravenous Fenretinide Emulsion for Patients With Relapsed/Refractory Peripheral T-cell Lymphomas
A Phase 2 study testing Fenretinide in people with Peripheral T-cell Lymphoma, run by CerRx, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Fenretinide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2016to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
Kerry M. Barnhart, Ph.D. contact
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
David Reagan, 404-778-3255, david.j.reagan@emory.edu
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Sandy Li, RN, 214-820-1530, sandy.li@bswhealth.org
- Recruiting
University of Texas, Southwestern
Dallas, Texas, 75390
Donglan Xia, 214-648-6637, Donglan.Xia@utsouthwestern.edu
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Shelby Burlew, 480-256-5414, shelby.burlew@bannerhealth.com
- Recruiting
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, 29607
Gretchen Reid, 864-603-6218, Gretchen_Reid@bshsi.org
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Lauren Pascual, 551-996-3129, lauren.pascual@hackensackmeridian.org
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Christine Duran, 323-865-0371, duran_c@med.usc.edu
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Bessie Bautista, 310-570-1457, BBautista@mednet.ucla.edu
- Recruiting
Norton Healthcare
Louisville, Kentucky, 40202
Dana Haycraft, 502-899-3366 ext. 187, dana.haycraft@nortonhealthcare.org
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Teresa Roberts, 502-562-4006, tlrobe14@exchange.louisville.edu
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205
Sara Pearson, 913-588-8292, spearson@kumc.edu
About this study
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)
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.
Read the 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.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Fenretinide
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenretinideDrug
Also called 4-HPR, (N-(4-hydroxyphenyl) retinamide
Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.
| Study group | Role | What they receive |
|---|---|---|
| Fenretinide emulsion | Experimental | 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. Receives: Drug: Fenretinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 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.
Measured: monitored from start of initial therapy until 30 days after the patient is removed from study therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startDec 2016
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry M. Barnhart, Ph.D., Study director, CerRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495415
- Sponsor's protocol ID
- FEN T-14
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28420721
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02495415
- Acronym / sponsor ID
- FEN T-14
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- CerRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenretinide emulsion | Experimental | Drug: FenretinidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenretinideAlso: 4-HPR, (N-(4-hydroxyphenyl) retinamideFenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients. | Drug | Fenretinide emulsion |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 28420721Mohrbacher 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry M. Barnhart, Ph.D. contact
Kerry M. Barnhart, Ph.D. study director
CerRx, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenretinide in people with Peripheral T-cell Lymphoma, run by CerRx, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerry M. Barnhart, Ph.D. (kerry.barnhart@cerrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.