Immunochemotherapy: Do platin-based chemotherapeutics enhance dendritic cell vaccine efficay in melanoma patients? - DC immunochemotherapy

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 54 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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

•- 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