endometrial cancer
Conditions
Interventions
Our study population consists of 8 mEC patients who receive chemotherapy with
carboplatin and paclitaxel in a weekly schedule on week 1, 2, 3 and week 5, 6
and 717. In week 8, myeloid and plasmacyto
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to evaluate the immune responses towards tumor peptide-loaded nDC in mEC patients. We will study: a) functional responses and tetramer analysis of DTH infiltrating lymphocytes against tumor peptides and b) type I IFN gene expression in PBMC shortly after vaccination, and c) proliferative, effector cytokine- and humoral responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are the safety, feasibility and quality of life of nDC vaccinations. | — |
Countries
Netherlands
Outcome results
None listed