A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

Who is this study for? Patients with relapsed/refractory T-cell non-Hodgkin's lymphoma
What treatments are being studied? Fenretinide
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):

‣ Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).

⁃ Nodal TCL: Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies\[98\] (Appendix A).

• For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.

• Relapsed or refractory (R/R) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).

• Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.

• Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.

• Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.

• For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are eligible.

• Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment. If the PI assesses that it is in the best interest of the patient to have a shorter washout period, they may submit a written request to the sponsor and can enroll the patient after written approval has been received.

• Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective contraceptive methods for the duration of the study. A urine pregnancy test is required just prior to the first dosing session of every treatment cycle.

• ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).

• Life expectancy greater than 6 months.

• Patients must have normal organ and marrow function as defined below:

• Leukocytes ≥ 3,000/μL

• Absolute neutrophil count ≥ 1,500/μL

• Platelets ≥ 100,000/μL

• Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible

• AST (SGOT) and ALT (SGPT) within institutional upper limit of normal

• Creatinine clearance ≥60 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation

∙ Or if the patient were to have bone marrow involved NHL, the hematological requirements should be as listed below:

• Absolute neutrophil count ≥ 500/μL

• Platelets ≥ 50,000/μL

• Triglyceride blood level (fasting) \<300mg/dL at time of enrollment (normal: \<150mg/dL; borderline high = 150-199mg/dL; high = 200-499mg/dL; very high = 500mg/dL or higher).

• ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and/or urine pregnancy test before beginning the investigational study treatment. If you are sexually active, it is important that you not become pregnant or father a child because this medication may be harmful to your unborn child. Patients must discuss pregnancy plans with their doctor before enrolling in this study and agree that they will take the appropriate precautions not to become pregnant while enrolled in the study.

∙ If there is any chance that patient can get pregnant, patient must either agree to not have vaginal intercourse or you must use two (2) types of birth control (hormonal, barrier method of birth control, abstinence) at the same time. These birth control methods must be used from the time of enrollment, all during investigational study treatment including during temporary breaks from therapy, and for at least 4 months after the last dose of ST-001.

∙ • Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.

Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Scottsdale
California
City of Hope Medical Foundation
RECRUITING
Duarte
University of Southern California
RECRUITING
Los Angeles
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Michigan
University of Michigan
RECRUITING
Ann Arbor
Barbara Ann Karmanos Cancer Institute Wayne State University
RECRUITING
Detroit
New York
Columbia University
RECRUITING
New York
Pennsylvania
University of Pittsburgh Medical Center (UPMC)
RECRUITING
Pittsburgh
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Louis M Scarmoutzos, PhD
lou@scitechdevelopment.com
(617) 283-2182
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2025-11
Participants
Target number of participants: 46
Treatments
Experimental: Phase 1
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)
Sponsors
Leads: SciTech Development, Inc.

This content was sourced from clinicaltrials.gov

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