Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • 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

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2023-056
    NCT ID
    • NCT04234048
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


    Primary Objective:

    • To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ST-001 12.5 mg/mL for IV infusion (ST-001) in patients with Relapsed/Refractory T-cell non-Hodgkin’s lymphoma when ST-001 is administered via 4-hour IV infusion daily for five consecutive days, q3weeks.

    Secondary Objectives:

    • To describe the toxicity profile of ST-001 in patients with CTCL and other T-cell NHL.
    • To observe and record anti-tumor activity. The previous activity seen with an earlier formulation of fenretinide in the same patient population suggests a likelihood of therapeutic benefit. Thus, patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
    • To investigate the clinical pharmacology of ST-001 12.5 mg/mL for IV infusion.
    • To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.
    • To evaluate potential mechanisms of action of ST-001 with pharmacodynamic biomarkers:
      • ST-001 increases CTCL cell surface expression of NKG2D receptor ligands, while reducing expression of immunosuppressive cytokines, thereby increasing cytolysis by both CD8+ CTLs and NK cells
      • ST-001 reduces expression of cytokine ligands for IL-2, -15, -21 receptors, thereby reducing CTCL proliferation driven by constitutive over-expression of the IL2RA subunit
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions
    Phone: 800-527-6266