Phase I/II study: on the toxicity and effects of combining the p53 synthetic long peptides vaccine with either Imiquimod or Interferon-alfa to induce polarized p53-specific immunity in patients treated for colorectal cancer - p53-SLP vaccine in combination with Imiquimod or IFNa

Conditions: adult both male and femal patients treated for colorectal cancer

Registration Number: EUCTR2008-004611-35-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients must meet all the following criteria in order to be included in the study:
1.Histological proven colorectal carcinoma
2.At least one month after last treatment
3.Life expectance of more than 6 months
4.Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines
5.Patients must be 18 years or older.
6.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
7.Patients must be ambulatory, with a WHO performance status of 0 to 1
8.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
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

Exclusion Criteria

Patients who meet the following exclusion criteria will not be eligible for admission to the study:
1.Radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the enrolment visit
2.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
3.History of serious liver or kidney dysfunction, heart condition or thyroid disorder
4.History of a second malignancy except curatively treated low-stage tumours with a histology that can be differentiated from colorectal cancer
5.Receipt of another investigational product within the previous 4 weeks or at any time during the study period.
6.Receipt of prior P53 directed immunotherapy
7.Any condition that in the opinion of the investigator could interfere with the conduct of the study