Single-step antigen loading and TLR activation of dendritic cells by mRNA electroporation for vaccination in stage III and IV melanoma patients - Trimix DC vaccinations in melanoma patients

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2009年9月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•For both stage III and IV melanoma
•- histologically documented evidence of melanoma
•- stage III or IV melanoma according to the 2001 AJCC criteria
•- HLA-A2.1 phenotype is required
•- melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
•- WHO performance status 0-1 (Karnofsky 100-70%)
•- life expectancy >3 months
•- age 18-70 years
•- no clinical signs or symptoms of CNS metastases
•- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l,
•serum crea-tinine <150 µmol/l, serum bilirubin <25 µmol/l
•- normal serum LDH (=450 U/l)
•- expected adequacy of follow-up
•- no pregnant or lactating women
•- written informed consent
•For stage III melanoma
•- interval since regional lymph node dissection is <2 months
•For stage IV melanoma
•- at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and limited tumor burden, according to the responsible physician
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- prior chemotherapy, immunotherapy or radiotherapy <4 weeks prior to planned
•vaccination or presence of treatment-related toxicity
•- 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, 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 disease
•- any serious clinical condition that may interfere with the safe administration of DC

发起方

Radboud University Nijmegen Medical Centre