NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

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 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)

Conditions3

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