TIL Therapy for Metastatic Ovarian Cancer
Condition: Metastatic Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive
      clinical results with durable complete responses in patients with metastatic melanoma. The
      TILs are isolated from patients own tumor tissue followed by in vitro expansion and
      activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
      preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
      Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.

      Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma,
      including Ovarian Cancer. In this study TIL therapy is administered to patients with
      metastatic Ovarian Cancer.
    

Detailed description: 
      Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive
      clinical results with durable complete responses in patients with metastatic melanoma. The
      TILs are isolated from patients own tumor tissue followed by in vitro expansion and
      activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
      preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
      Interleukin-2 is administered to support T cell acitivation and proliferation in vivo.

      Objectives:

      To evaluate safety and feasibility when treating patients with metastatic ovarian cancer with
      ACT with TILs.

      To evaluate treatment related immune responses To evaluate clinical efficacy

      Design:

      Patients will be screened with a physical exam, medical history, blood samples and ECG.

      Patients will undergo surgery to harvest tumor material for TIL production. Patients is
      admitted day -8 in order to undergo lymphodepleting chemotherapy with cyclophosphamide and
      fludara starting day -7.

      On day 0 patients receive TIL infusion and shortly after starts IL-2 infusion continually
      following the decrescendo regimen.

      The patients will followed until progression or up to 5 years
    

Intervention name(s): Cyclophosphamide; Fludarabine; TIL infusion; Interleukin-2
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.; Fludarabine 25 mg/m2 is administered on day -5 to day -1.; The maximum number of expanded TILs are infused over 30-45 minutes on day 0.; Interleukin-2 is administered as a continous i.v. infusion in a decrescendo regimen (18 MIU/m3 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU/m2 IL-2 over 24 hours followed by 4,5 MIU/m2 IL-2 over another 24 hours for three days).
Other intervention name(s): Cyclophospamide; Fludarabinephosphate; Fludara; T Cell infusion; IL-2; Proleukin
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment