Metastatic Ovarian Cancer Clinical Trial
Official title:
T Cell Therapy for Patients With Metastatic Ovarian Cancer
Verified date | August 2017 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | April 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Histologically confirmed high grade serous adenokarcinoma ovarian cancer metastasis available for surgical resection (more than 1 cm3) and residual measurable disease after resection - 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: - Other malignancies, unless followed for = 5 years with no sign of disease - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Cancer Immune Therapy Dept. of Hematology/oncology | Copenhagen | Herlev |
Lead Sponsor | Collaborator |
---|---|
Inge Marie Svane |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0-24 weeks | |
Secondary | Treatment related immune responses | To evaluate the immunological impact of TIL therapy for patients with metastatic Ovarian Cancer | Up to 12 months | |
Secondary | Objective response rate | Clinical responses will be evaluated by RECIST 1.1. | Up to 12 months | |
Secondary | Overall Survival | Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve. | Up to 12 months | |
Secondary | 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. | Up to 12 months |
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