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

未提供0 个研究点目标入组 8 人开始时间: 2019年5月13日最近更新: 2021年12月13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
•oresistant to hormonal therapy
•oineligible 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•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

发起方

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