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 patienten

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•All patients:
•- histologically documented evidence of melanoma
•- stage III or IV melanoma according to the 2001 AJCC criteria
•- 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 creatinine <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
•and in addition:
•Stage III melanoma
•- interval since radical regional lymphnode dissection is <2 months
•Stage IV melanoma
•- at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments

•- 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

niversitair Medisch Centrum Sint Radboud