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

Radboud Universitair Medisch Centrum0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•* 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

•* 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

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