Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2015-07-31
2017-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patient group
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.
Cyclophosphamide
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine
Fludarabine 25 mg/m2 is administered on day -5 to day -1.
TIL infusion
The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
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).
Interventions
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Cyclophosphamide
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine
Fludarabine 25 mg/m2 is administered on day -5 to day -1.
TIL infusion
The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression/reccurence of ovarian cancer after 1. line platin based chemotherapy or progression/reccurence after 2. line or additional chemotherapy
* ECOG performance status 0-1
* Life expectancy \> 6 months
* No significant toxicity from prior treatments, except sensoric- and motoric neuropathia and/or alopecia
* Adequate renal, hepatic and hematological function
* Women of childbearing potentil (WOCBP) must be using an effective method of contraception during treatment and for at least 6 months after completion of treatment
* Able to comprehend the information given and willing to sign informed consent
Exclusion Criteria
* Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
* Serious medical or psychiatric comorbidity
* Creatinine clearance \< 70 ml/min
* Acute or chronic infection with e.g. HIV, hepatitis, tuberculosis
* Severe and active autoimmune disease
* Pregnant and nursing women
* Need for immunosuppressive treatment, e.g. corticosteroids or methotrexate
* Concomitant treatment with other experimental drugs
* Patients with uncontrolled hypercalcemia
* Less than four weeks since prior systemic antineoplastic treatment at the time of treatment
18 Years
70 Years
FEMALE
No
Sponsors
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Inge Marie Svane
OTHER
Responsible Party
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Inge Marie Svane
M.D., Professor
Principal Investigators
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Inge Marie Svane, Prof., MD
Role: STUDY_DIRECTOR
Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730
Magnus Pedersen, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Cancer Immune Therapy, Dept of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730
Locations
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Center for Cancer Immune Therapy Dept. of Hematology/oncology
Copenhagen, Herlev, Denmark
Countries
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References
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Westergaard MCW, Andersen R, Chong C, Kjeldsen JW, Pedersen M, Friese C, Hasselager T, Lajer H, Coukos G, Bassani-Sternberg M, Donia M, Svane IM. Tumour-reactive T cell subsets in the microenvironment of ovarian cancer. Br J Cancer. 2019 Feb;120(4):424-434. doi: 10.1038/s41416-019-0384-y. Epub 2019 Feb 5.
Andersen R, Donia M, Westergaard MC, Pedersen M, Hansen M, Svane IM. Tumor infiltrating lymphocyte therapy for ovarian cancer and renal cell carcinoma. Hum Vaccin Immunother. 2015;11(12):2790-5. doi: 10.1080/21645515.2015.1075106.
Other Identifiers
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GY1508
Identifier Type: -
Identifier Source: org_study_id
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