Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
SciTech Development, Inc.
Study ID
NCT04234048
Phase
PHASE1
Status
Recruiting
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Conditions

  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous T-Cell Lymphoma, Unspecified
  • Cutaneous T-cell Lymphoma
  • Cutaneous/Peripheral T-Cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Mycosis Fungoides
  • Peripheral T-Cell Lymphoma, Not Classified
  • Peripheral T-cell Lymphoma
  • Primary Cutaneous T-cell Lymphoma
  • Sézary's Disease
  • T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fenretinide — DRUG
    Accelerated Phase 1a 100% Dose escalation in 8 single-patient cohorts Standard Phase 1a 40% Dose escalation in 3-patient cohorts X 3 cohorts Phase 1b Dosed at MTD in 20 patients as disease-specific expanded cohort

Study Details

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

Key Dates

Start date
Dec 18, 2023
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Breanna Keller
Aaron R Mangold, M.D. (PRINCIPAL_INVESTIGATOR)
City of Hope Medical FoundationDuarteCalifornia91010
Tracey Nguyen
Christiane Querfeld, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90007
Christine Duran
Ann F Mohrbacher, M.D. (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Rebecca Reed, MPH-PHP
[email protected]
303-724-4874
Brad Haverkos, M.D. (PRINCIPAL_INVESTIGATOR)
Northwestern University, Robert H. Lurie Comprehensive Cancer CenterChicagoIllinois60611
Benjamin Joslin, MPH, CCRC
Jonathan Moreira, M.D. (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Tina Jones
Ryan A Wilcox, MD, PhD (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer Institute Wayne State UniversityDetroitMichigan48201
Erik Carr
Dipenkumar Modi, M.D. (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Anxhela Kalia
Barbara Pro, M.D. (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15219
Charity L Ruhl, LPN
Oleg E Akilov, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Alda J Ashu, BSN, RN, OCN
Auris O Huen, MD, PharmD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic Arizona· Scottsdale, AZCity of Hope Medical Foundation· Duarte, CAUniversity of Southern California· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, CONorthwestern University, Robert H. Lurie Comprehensive Cancer Center· Chicago, ILUniversity of Michigan· Ann Arbor, MI

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