TIL Therapy for Metastatic Ovarian Cancer

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inge Marie Svane
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Interleukin-2

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