Myeloid and plasmacytoid blood dendritic cells for immunotherapy of stage III melanoma patients scheduled for radical lymph node dissection - myDC/pDC in stage III melanoma patients before dissection

Radboud University Nijmegen Medical Centre0 个研究点目标入组 28 人开始时间: 2014年7月9日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•-stage III melanoma with enlarged lymph nodes according to the 2001 AJCC criteria
•- cytological or histological documented evidence of stage III melanoma
•- HLA-A2.1 positive
•- WHO performance status 0-1 (Karnofsky 100-70)
•- life expectancy =3 months
•- age 18-75 years
•- no clinical signs or symptoms of CNS metastases
•- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum creatinine <150 µmol/l, serum bilirubin <25 µmol/l
•- normal serum LDH (=250 U/l)
•- expected adequacy of follow-up
•- no pregnant or lactating women
•- written informed consent
•- radical regional lymphnode dissection is scheduled, but not yet performed
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•- any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed
•more than 4 weeks prior to planned vaccination
•- history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
•- serious active infections, known HbsAg or HIV positive, or autoimmune diseases or organ allografts
•- concomitant use of immunosuppressive drugs
•- known allergy to shell fish (since it contains KLH)
•- rapidly progressive symptomatic disease
•- acute kidney injury or chronic severe kidney disease
•- any serious clinical condition that may interfere with the safe administration of DC
•- expected adequacy of follow-up
•- no pregnant or lactating women
•- written informed consent
•- radical regional lymphnode dissection is scheduled

发起方

Radboud University Nijmegen Medical Centre