Phase I study: determining toxicity and immunity of the p53 synthetic long peptides vaccine combined with Interferon-alfa in patients treated for colorectal cancer - p53-SLP vaccine in combination with IFNa

eids Universitair Medisch Centrum0 个研究点目标入组 10 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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•- Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines
•- Patients must be 18 years or older.
•- Histological proven colorectal carcinoma
•- At least one month after last treatment
•- Life expectance of more than 6 months
•- Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study
•- Patients must be ambulatory, with an WHO performance status of 0 to 1
•- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; conditions should be discussed with the patient before registration in the trial
•- Baseline laboratory findings; haemoglobin > 6.0mmol/L, white blood cells (WBC) > 3,000 x 109/L, lymphocytes > 1,000 x 109/L, platelets > 100 x 109/L, HIV- and HBV-negative

•- History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients
•- History of a second malignancy except curatively treated low-stage tumours with a histology that can be differentiated from colorectal cancer
•- Any condition that in the opinion of the investigator could interfere with the conduct of the study
•- Radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the enrolment visit
•- Receipt of another investigational product within the previous 4 weeks or at any time during the study period
•- Receipt of prior P53 directed immunotherapy

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