Status:
UNKNOWN
Adoptive T Cell Therapy in Patients With Recurrent Ovarian Cancer
Lead Sponsor:
Leiden University Medical Center
Conditions:
Ovarian Cancer Recurrent
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The clinical benefit of standard treatment for patients with epithelial ovarian cancer (EOC) are poor. Ovarian cancer is a highly immunogenic tumor and good survival is tightly linked to the presence ...
Detailed Description
Study the feasibility and safety of TIL administration in the window of opportunity created by carboplatin-paclitaxel chemotherapy with or without interferon alpha (IFNα). Furthermore, exploratory stu...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically proven epithelial ovarian cancer (EOC).
- Recurrent ovarian cancer amenable to carboplatin and paclitaxel chemotherapy. Patient with primary stage III or IV EOC can participate in the pre-OVACURE to collect rest tumor during debulking surgery for TILs preservation, so TILs will be available in case of recurrent disease will develop in the future.
- 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:
- Lab Parameter Range Hemoglobin ≥ 6,0 mmol/l Granulocytes ≥ 1,500/µl Lymphocytes ≥ 700/µl Platelets ≥ 100,000/µl Creatinine clearance ≥ 50 min/ml Serum bilirubin ≤ 40 mol/l ASAT and ALAT ≤ 5 times the normal upper limit LDH ≤ 2 times the normal upper limit
- Viral tests:
- Negative for HIV type 1/2, HTLV and TPHA
- No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
- No antibodies against HCV (hepatitis C virus) in the serum
- Able and willing to give valid written informed consent.
- Prior treatment, including immunotherapy e.g. with anti-PD(L)1, is allowed but systemic therapy and radiotherapy must have been discontinued for at least two weeks before study entry.
- Patients should have disease progression.
Exclusion
- 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 in situ cervical or vulva carcinoma.
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04072263
Start Date
August 1 2018
End Date
December 1 2021
Last Update
April 1 2021
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA