An exploratory study: Dendritic cells for immunotherapy of metastatic endometrial cancer patients

Phase 2

Completed

• Conditions: endometrial cancer; 10038594

• Registration Number: NL-OMON47953
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-01
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

* women * 18 years old with histologically confirmed stage IV or metastatic carcinoma of the endometrium of the endometroid, serous or carcinosarcoma type.
* Hormone receptor negative or
o resistant to hormonal therapy
o ineligible for hormonal therapy because of other reasons
* eligible for treatment with carboplatin paclitaxel combination chemotherapy
* Life expectancy * 6 months
* WHO/ECOG performance status 0-1 (Karnofsky index 100-70)
* WBC >2.0*109/l, neutrophils >1.5*109/L lymphocytes >0.8*109/L, platelets >100*109/L, hemoglobin >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubin <1.5 x ULN (exception: Gilbert*s syndrome is permitted)
* Expression of survivin and/or muc1 on tumor material
* 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
* Written informed consent

Exclusion Criteria

* Eligible for hormonal therapy
Uncontrolled hypercalcemia
* History of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma
* Known allergy to shell fish
* Heart failure (NYHA class III/IV)
* Serious active infections
* Active hepatitis B, C or HIV infection
* Active syphilis infection
* Autoimmune diseases (exception: vitiligo is permitted)
* Organ allografts
* An uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
* Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent
* Any serious clinical condition that may interfere with the safe administration of DC vaccinations
* Unable to undergo a tumor biopsy
* Pregnancy or insufficient anti-conception if reproduction is still possible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is to evaluate the immune responses towards<br /><br>tumor peptide-loaded nDC in mEC patients. We will study: a) functional<br /><br>responses and tetramer analysis of DTH infiltrating lymphocytes against tumor<br /><br>peptides and b) type I IFN gene expression in PBMC shortly after vaccination,<br /><br>and c) proliferative, effector cytokine- and humoral responses. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are the safety, feasibility and quality of life of nDC<br /><br>vaccinations.</p><br>