TIL Therapy for Metastatic Ovarian Cancer
Metastatic Ovarian Cancer
About this trial
This is an interventional treatment trial for Metastatic Ovarian Cancer
Eligibility Criteria
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
Sites / Locations
- Center for Cancer Immune Therapy Dept. of Hematology/oncology
Arms of the Study
Arm 1
Experimental
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.