NCT02482090

TIL Therapy for Metastatic Ovarian Cancer

T Cell Therapy for Patients With Metastatic Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
DRUG	Fludarabine	Fludarabine 25 mg/m2 is administered on day -5 to day -1.
BIOLOGICAL	TIL infusion	The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
DRUG	Interleukin-2	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).

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-01
• Completion: 2017-04-01
• First posted: 2015-06-25
• Last updated: 2017-08-16

Locations

1 site across 1 country: Denmark