cancer of the ovary Epithelial Ovarian Cancer
Conditions
Interventions
Cohort 1 (n=3-6): Add TIL to standard chemotherapy (carboplatin+paclitaxel).
TIL will be administered 2 weeks after the 2nd, 3rd and 4th chemotherapy cycle
Cohort 2: (n=3-6) Add TIL plus IFNa to stan
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 18 years. • OVACURE: Histologically proven epithelial ovarian cancer (EOC). Pre-OVACURE: Patients with stage IIIc or IV EOC that are treated with first line surgery can participate in the pre-OVACURE for TIL preservation out of the surgical specimen. In case of recurrent disease these TILs can be used. • Recurrent ovarian cancer • Presence of measurable progressive disease according to RECIST version 1.1 or elevated CA125>2 times the upper normal limit (UNL) within 3 months and confirmed. • Expected survival of at least 3 months. • WHO performance status 0-2. • Within the last 2 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Hemoglobin >= 6,0 mmol/l Granulocytes >= 1,500/µl Lymphocytes >= 700/µl Platelets >= 100,000/µl Creatinine clearance >= 50 min/ml Serum bilirubin
Exclusion criteria
Exclusion criteria: • Patients with brain metastases. • Clinically significant heart disease (NYHA Class III or IV). • Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study. • Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion. • Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and premalignant diseasein. • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. • Lack of availability for follow-up assessments. • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - TIL (plus INFa) related toxicity according to NCI CTCAE v4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| Signs of activity: o Best overall response according to RECIST 1.1 and immune response criteria (irRC). o Disease control rate (DCR: CR+PR+SD) at 6 months. o Progression free survival and overall survival. o Analysis of underlying mechanisms by evaluation of hypothesis-related immune parameters (including immune modulation by chemotherapy, TIL and IFNa and functional capacity of TIL). | — |
Countries
Netherlands
Outcome results
None listed