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Retinoid
Fenretinide for T-Cell Lymphoma
Phase 1
Recruiting
Led By Brad Haverkos, M.D.
Research Sponsored by SciTech Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug to treat T-cell non-Hodgkin's lymphoma, a cancer of the immune system.
Who is the study for?
Adults with specific types of T-cell non-Hodgkin's lymphoma who have not responded to at least two previous treatments can join. They should be relatively healthy, able to perform daily activities, and have a life expectancy over 6 months. Pregnant or breastfeeding women, HIV patients on certain therapies, and those with active hepatitis or CNS disease cannot participate.
What is being tested?
The trial is testing ST-001 nanoFenretinide, a new form of the drug fenretinide delivered in tiny particles designed for treating T-cell NHL. Participants will receive this treatment to see how well it works against their cancer.
What are the potential side effects?
Potential side effects may include reactions similar to other retinoids such as dry skin, mouth and eyes; headaches; bone pain; nausea and vomiting; liver function changes; sensitivity to sunlight; and blood lipid abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Activation of cytolytic T-lymphocytes (CTLs) and natural killer (NK) cells after ST-001 treatment.
Fenretinide Cp(plateau), half-life (t1/2), and calculated parameters of Clearance and Volume of Distribution
Number of participants with complete response (CR) or partial response (PR) to ST-001
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1Experimental Treatment1 Intervention
Accelerated Phase 1a + Standard Phase 1a + Phase 1b
Accelerated Phase 1a
Up to 9 patients for accelerated phase 1a (single patient cohort); dose levels of ST-001 nanoFenretinide (mg/m\^2/day X 5 days every 21 days):
Dose Level 1 1.25 (1 patient) Dose Level 2 2.5 (1 patient) Dose Level 3 5.0 (1 patient) Dose Level 4 10 (1 patient) Dose Level 5 20 (1 patient) Dose Level 6 40 (1 patient) Dose Level 7 80 (1 patient) Dose Level 8 160 (1 patient) Dose Level 9 320 (1 patient)
Standard Phase 1a
Up to 15 patients for standard phase 1a (3+3 design); dose level (mg/m2/day X 5 days every 21 days):
Dose Level 10 640 (3-6 patients) Dose Level 11 896 (3-6 patients) Dose Level 12 1,254 (3-6 patients) Dose Level 13 1,756 (3-6 patients)
Phase 1b
20 patients for phase 1b at the maximum tolerated dose (MTD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenretinide
Not yet FDA approved
Find a Location
Who is running the clinical trial?
SciTech Development, LLCLead Sponsor
Rush University Medical CenterOTHER
436 Previous Clinical Trials
249,318 Total Patients Enrolled
2 Trials studying Mycosis Fungoides
169 Patients Enrolled for Mycosis Fungoides
Brad Haverkos, M.D.Principal InvestigatorUniversity of Colorado - Anschutz Medical Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with fenretinide.I have or had a brain or spinal cord disease.I do not have any uncontrolled illnesses.I have at least one tumor that can be measured.I am currently taking other medications.I use certain medications like acetaminophen carefully and under close watch.My lymphoma is at a specific stage and affects the skin or lymph nodes.My condition has not improved or has returned after treatment.I do not have an active hepatitis infection.It has been over 4 weeks since my last cancer treatment.I am HIV-positive and on combination antiretroviral therapy.My condition did not improve after two different drug treatments.I need treatment with strong CYP3A inducers.I need treatment with strong to moderate CYP3A inhibitors.I have a diagnosed eye condition.My diagnosis is a specific type of T-cell lymphoma confirmed by lab tests.I have not had chemotherapy or radiotherapy recently.My lymphoma is not one of the specified T-cell types.I am 18 years old or older.I am fully active or can carry out light work.My organs and bone marrow are functioning normally.I will use barrier methods of contraception if my partner can have children.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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