We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients (DECENDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04212377
Recruitment Status : Completed
First Posted : December 27, 2019
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
Stichting Katholieke Universiteit
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Prevention of infectious diseases through immunization is one of the greatest achievements of modern medicine. Nonetheless, considerable challenges remain for improving the efficacy of existing vaccines for therapeutic immunizations for diseases such as cancer. The investigators were amongst the first groups worldwide that introduced tumor antigen-loaded dendritic cell (DC)-based vaccines in the clinic1-3. Effective immune responses and favorable clinical outcomes have indeed been observed4-7. Thus far, mainly conventional in vitro generated monocyte-derived DCs (moDC) have been used in clinical trials worldwide. In the past 14 years the investigators have treated more than 375 patients and proven that DC therapy is feasible and non-toxic. The investigators observed that long lasting tumor specific T cell-mediated immunological responses are clearly linked to increased progression free survival as well as overall survival8.

In conclusion, based on all these observations the investigators are convinced that pDC and myDC employ different, and probably more optimal mechanisms to combat cancer. In addition, based on in vitro data and preclinical studies that suggest that blood pDC and myDC act synergistically, the investigators hypothesize that the combination of myDC and pDC may induce stronger anti-tumor immune responses as compared to pDC or myDC alone, or moDC.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Biological: Dendritic Cells for endometrial cancer Phase 2

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a single arm exploratory, single-centre study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study: Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : March 9, 2021
Actual Study Completion Date : March 9, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: exploratory
single arm exploratory, single-centre study
 Biological: Dendritic Cells for endometrial cancer
Our study population consists of 8 mEC patients who receive carboplatin / paclitaxel chemotherapy in a weekly schedule on weeks 1, 2, 3 and weeks 5,6 and 7. In week 8, myeloid and plasmacytoid DC (nDC) are loaded with tumor lysate and MUC1 and survivin PepTivators, injected intranodally. An extensive immuno-motoring will be performed on all patients. Patients who show stable disease, partial response, or full response continue with extended three-week chemotherapy regimens with intranodal injections of nDC at weeks 17, 20, and 23.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immunologic efficacy of tumor-peptide loaded nDC in mEC patients [ Time Frame: 1 year ]
    Immunomonitoring including: a) functional response and tetramer analysis of DTH infiltrating lymphocytes against tumor peptides


Secondary Outcome Measures :
  1. toxicity: Adverse Events [ Time Frame: study start till week 26 ]
    Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events version 4.0

  2. Health- related Quality of Life [ Time Frame: Baseline, week 15 and week 26 ]
    Health-related quality of life, assessed using a composite of the European Organisation of Research and Treatment of Cancer (EORTC) core quality of life questionaire (QLQ C-30) of life will be assessed by the general EORTC-QLQ C30

  3. feasibility [ Time Frame: Baseline, week 8, week 17 and week 24 and week 26 ]
    number of subjects with a successful vaccination on CT scan


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   No
Criteria

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
  • resistant to hormonal therapy
  • 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

Postmenopausal is defined as:

  • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;
  • Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50,
  • radiation-induced oophorectomy with last menses >1 year ago,
  • chemotherapy-induced menopause with >1 year interval since last menses
  • or surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • Written informed consent

Exclusion criteria

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04212377


Locations
Layout table for location information
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Stichting Katholieke Universiteit
Investigators
Layout table for investigator information
Principal Investigator: Jolanda de Vries, Prof. Dr. Radboud Umiversity Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04212377    
Other Study ID Numbers: NL68332.000.18
First Posted: December 27, 2019    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
Endometrial Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases