A Phase 1 interventional study of Cyclophosphamide and Fludarabine in Metastatic Ovarian Cancer, sponsored by Inge Marie Svane. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Inge Marie Svane · Phase 1, Interventional, and Treatment
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
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Inge Marie Svane is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
All patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.
Drug: Cyclophosphamide · Drug: Fludarabine · Biological: TIL infusion · Drug: Interleukin-2
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Also known as: Cyclophospamide
Fludarabine 25 mg/m2 is administered on day -5 to day -1.
Also known as: Fludarabinephosphate, Fludara
The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Also known as: T Cell infusion
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).
Also known as: IL-2, Proleukin
Number and type of reported adverse events
Determine the safety of the administration of TIL therapy including lymphodepleting chemotherapy and Interleukin-2 for patients with metastatic Ovarian Cancer by reporting adverse events according to CTCAE v. 4.0.
Time frame: 0-24 weeks
Treatment related immune responses
To evaluate the immunological impact of TIL therapy for patients with metastatic Ovarian Cancer
Time frame: Up to 12 months
Objective response rate
Clinical responses will be evaluated by RECIST 1.1.
Time frame: Up to 12 months
Overall Survival
Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.
Time frame: Up to 12 months
Progression free survival
Progression free survival (PFS), defined as the time from treatment initiation to disease progression, relapse or death due to any cause, which ever comes first, will be described with Kaplan Meier curve.
Time frame: Up to 12 months
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Inge Marie Svane