T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer
Condition: COL6A3 Positive; HLA-A*0201 Positive Cells Present; PRAME Positive; Recurrent Ovarian Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/Ib trial studies the side effects and best dose of utomilumab and how well it
      works with CD8-positive T-lymphocyte (T-cell infusion) and aldesleukin in treating patients
      with ovarian cancer that has come back. Aldesleukin may stimulate white blood cells to kill
      ovarian cancer cells. Giving white blood cells (T-cells) that have been activated by a
      vaccine with aldesleukin may kill more tumor cells. Immunotherapy with utomilumab, may induce
      changes in body's immune system and may interfere with the ability of tumor cells to grow and
      spread. Giving T-cell infusion with aldesleukin and utomilumab may work better in treating
      patients with ovarian cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Assess the safety and toxicity of adoptively transferred central memory-type CTL targeting
      ovarian cancer antigens administered alone, and in combination with, utomilumab, an agonistic
      anti-CD137 antibody, in patients with platinum-resistant ovarian cancer.

      II. Evaluate the functional and numeric in vivo persistence of adoptively transferred central
      memory-type CTL with and without utomilumab.

      SECONDARY OBJECTIVES:

      I. Evaluate the anti tumor effect of adoptively transferred central memory-type CTL targeting
      ovarian cancer antigens as measured by best overall response rate (BORR) and progression free
      survival (PFS).

      OUTLINE: This is a dose escalation study of utomilumab.

      Patients undergo leukapheresis. Patients then receive cyclophosphamide intravenously (IV) on
      day -2, CD8-positive T-lymphocyte via infusion on day 0, and aldesleukin subcutaneously (SC)
      every 12 hours for 14 days. Beginning 24 hours after CD8-positive T-lymphocyte, patients also
      receive utomilumab IV over 90 minutes on days 1, 29, 57, 85, 113, and 141 in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at days 3, 7, 14, 22, 28, 35,
      43, 49, 56, 64, 70, 77, 84, 112, and 140.
    

Intervention name(s): Aldesleukin; CD8-Positive T-Lymphocyte; Cyclophosphamide; Leukapheresis; Utomilumab
Intervention type(s): Biological; Drug; Drug; Procedure; Biological
Intervention description(s): Given IV; Given IV; Given IV; Undergo leukapheresis; Given IV
Other intervention name(s): 125-L-Serine-2-133-interleukin 2; Proleukin; r-serHuIL-2; Recombinant Human IL-2; Recombinant Human Interleukin-2; CD8 Cell; CD8 Lymphocyte; CD8 Lymphocytes; CD8+ T Cell; CD8+ T Lymphocyte; CD8+ T Lymphocytes; CD8+ T-Lymphocyte; CD8-Positive Lymphocyte; CD8-Positive Lymphocytes; CD8-Positive T-Lymphocytes; T8 Cell; T8 Cells; T8 Lymphocyte; T8 Lymphocytes; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CTX; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cyclostine; Cytophosphan; Cytophosphane; Cytoxan; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; Leukocytopheresis; Therapeutic Leukopheresis; PF 05082566; PF 5082566; PF-05082566; PF-2566
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Interleukin-2; Antibodies, Monoclonal; Immunoglobulin G
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment