NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for women with a specific type of ovarian cancer called high-grade serous epithelial ovarian cancer. The goal is to see if a special vaccine, made from the patient’s own tumor cells, can help their immune system fight the cancer better. This study is currently looking for women aged 18 and older who cannot have immediate surgery but need chemotherapy before an operation. To join, participants should have advanced-stage cancer (specifically stage IIIb or IIIc) and meet certain health criteria.

If you or a loved one is considering joining this trial, you can expect to receive the vaccine along with standard chemotherapy. The trial is designed to ensure safety and monitor how well the vaccine works in the body. Women with recurrent cancer, certain health conditions, or specific types of ovarian cancer that are not high-grade serous are not eligible to participate. It's also important that participants are not pregnant or planning to become pregnant during the trial. This study aims to provide more options for treating ovarian cancer and could contribute valuable information to future treatments.

Gender

FEMALE

Eligibility criteria

• • Inclusion criteria
• • 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 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 lymphocytes \>0.8x 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 criteria
• • Recurrent ovarian cancer
• • Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, low-grade serous, 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)