NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
Induction of Neo-Antigen Specific Cytotoxic T Cells by Autologous Tumor Lysate-loaded Specialized Cross-Presenting Dendritic Cells in Epithelial Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy, the NEODOC Study
Radboud University Medical Center
10 participants
Mar 17, 2023
INTERVENTIONAL
Conditions
Summary
This goal of this single arm, single center, exploratory phase I/II clinical trial is to learn more about the immunological efficacy, safety and feasibility of an autologous tumor lysate-loaded autologous XP-DC (cDC1)-based vaccine in patients with ovarian cancer.
Eligibility
Inclusion Criteria12
- Women over 18 years old with histologically confirmed primary epithelial ovarian cancer.
- Not amenable by primary debulking surgery and in need of neoadjuvant chemotherapy and interval debulking
- High-grade or low grade serous histology
- FIGO stage IIIb, IIIc, IVa or IVb if only lymph nodes ≤ 1cm above the diaphragm or in the groins
- Extensive abdominal spread of tumor
- WHO/ECOG performance status 0-1
- Neutrophils \>1.5x 109/L, platelets \>100x 109/L, hemoglobin \>5,6 mmol/L (9.0 g/dl), estimated glomerular filtration rate \> 45 ml/min/1.73m2 , AST/ALT \<3 x ULN, serum bilirubin \<1.5 x ULN (exception: Gilbert's syndrome is permitted)
- Expected adequacy of follow-up
- Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
- Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments;
- or surgical sterilisation (bilateral oophorectomy or hysterectomy).
- Informed consent
Exclusion Criteria16
- Recurrent ovarian cancer
- Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, mucinous, clear cell or carcinosarcoma
- Unable and/or unwilling to undergo standard chemotherapy and interval debulking surgery
- FIGO stage I-IIb, IIIa or IVb with liver, spleen or lung metastases or lymph nodes above the diaphragm or in the groins \> 1 cm
- History of any second malignancy, with the exception of adequately treated basal cell carcinoma, cervical cancer \> 5 years ago or early stage breast cancer \>10 years ago.
- Any serious clinical condition that may interfere with the safe administration of DC vaccinations
- Heart failure (NYHA class III/IV)
- Any uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
- Unable to undergo a tumor biopsy
- Pregnancy or insufficient anti-conception if reproduction is still possible
- Active infection of Hepatitis B, C, HIV and syphilis
- Serious other active infections
- Known allergy to shell fish
- Auto immune disease (exception: vitiligo is permitted)
- History of organ allografts
- Chronic treatment with systemic immunosuppressive drugs (i.e. more than 10 mg prednisolone equivalent)
Interventions
Autologous cross-presenting dendritic cells loaded with autologous tumor lysate and KLH
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05773859