Metastatic Ovarian Cancer Clinical Trial
Official title:
T Cell Therapy for Patients With Metastatic Ovarian Cancer
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03634150 -
Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01768156 -
Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer
|
N/A | |
| Completed |
NCT03287674 -
TIL Therapy in Combination With Checkpoint Inhibitors for Metastatic Ovarian Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05796973 -
Measuring Oncological Value of Exercise and Statin
|
Phase 3 | |
| Terminated |
NCT03277482 -
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
|
Phase 1 | |
| Recruiting |
NCT03150992 -
EDMONd - Elemental Diet in Bowel Obstruction
|
N/A | |
| Recruiting |
NCT03412526 -
Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian
|
Phase 2 | |
| Recruiting |
NCT01174121 -
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04611126 -
T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03242993 -
[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging
|
Phase 1 |