Dendritic cell vaccination for ovarian cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory phase I/II clinical trial aims to evaluate the immunological efficacy, safety, and feasibility of a specialized dendritic cell vaccine loaded with tumor lysate in patients with epithelial ovarian cancer. The trial will include 10 women with advanced stage III ovarian cancer who are not candidates for primary surgery and require neoadjuvant chemotherapy. The vaccine utilizes a specific type of dendritic cell known as XP-DC, which is designed to enhance immune responses against tumor neoantigens. Participants will receive XP-DC vaccinations while undergoing chemotherapy to assess the potential for improved treatment outcomes.

Why it matters

Who can join: the full rules

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 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 criteria

* 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)

Where it's running

• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: Nelleke Ottevanger, MD/PhD — Radboud University Medical Center
• Study coordinator: Bouke Koeneman, MD
• Email: bouke.koeneman@radboudumc.nl
• Phone: +31 (0)24 361 76 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.