p53 immunotherapy in patients treated for metastasised colorectal cancer.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Stage IV colorectal adenocarcinoma;
2. At least three months after last treatment;
3. Life expectance of more than 6 months;
4. Patients must be 18 years of age or older;
5. Female patients of childbearing potential must be neither pregnant nor breastfeeding and must have a negative serum pregnancy test within 14 days prior to entry. Female patients must agree to use effective contraception (birth control pills, condoms, approved implant, or IUD) during the course of this trial and for at least three months after the last injection;
6. Patients must be ambulatory, with an WHO performance status of 1 to 2;
7. 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;
8. Patient baseline laboratory values must be within the following ranges:Hb>6mmol/l; WBC 3*10e9; serum creatinine <175mmol/l;
9. Before patient registration, written informed consent must be given to the patient, according to Dutch regulations;
10. Patients must sign the written informed consent.

Exclusion Criteria

1. History of autoimmune disease or systemic intercurrent disease which might affect immunocompetence;
2. Other malignancies (previous or current), except adequately treated basal or squamous cell carcinoma of the skin;
3.Significant co-morbid medical conditions that in the estimation of the investigator would preclude the patient’s safe participation in the study or may interfere with study objectives;
4. Indication of active infectious disease, including Human Immunodeficiency Virus (HIV) AND Hepatitis B infection;
5. No radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to vaccination;
6. Receipt of another investigational product within the previous 4 weeks or at any time during the study period;
7. Receipt of prior P53 directed immunotherapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To define safety and immunogenicity of a p53 specific vaccine in combination with a defined adjuvant in patients treated for metastasised colorectal cancer.

Secondary Outcome Measures