p53 immunotherapy in patients treated for metastasised colorectal cancer

Phase 1

Completed

• Conditions: Tumour, Colorectal metastised cancer; Cancer; Colorectal cancer

• Registration Number: ISRCTN43704292
• Lead Sponsor: eiden University Medical Center (LUMC) (The Netherlands)

Brief Summary

2009 results in https://pubmed.ncbi.nlm.nih.gov/19188184/ (added 14/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-28
• Study Completion: 2008-08-01
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• 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 six 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 Intra-Uterine Device [IUD]) during the course of this trial and for at least three months after the last injection
6. Patients must be ambulatory, with a World Health Organisation (WHO) performance status of one to two
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: Haemoglobin (Hb) more than 6 mmol/l; White Blood Cells (WBC) 3 x 10^9; serum creatinine less than 175 mmol/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 four weeks prior to vaccination
6. Receipt of another investigational product within the previous four 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