p53 immunotherapy in patients treated for metastasised colorectal cancer

ISRCTN	ISRCTN43704292
DOI	https://doi.org/10.1186/ISRCTN43704292
Secondary identifying numbers	P06.019, NL793, NTR806

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 14/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr F M Speetjens
Scientific

Leiden University Medical Center (LUMC)
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2857
Email	f.m.speetjens@lumc.nl

Study information

Study design	Non-randomised clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Not specified
Study type	Treatment
Scientific title	p53 immunotherapy in patients treated for metastasised colorectal cancer
Study acronym	p53
Study hypothesis	p53 mutation in colorectal cancer provides an immunological window for immune therapy.
Ethics approval(s)	Approval received from the Committee Medical Ethics, Leiden University Medical Center, on April 13 2006 (ref: P06.019).
Condition	Tumour, Colorectal metastised cancer
Intervention	Patients will be vaccinated subcutaneously with a vaccine consisting of ten, overlapping long p53 peptides dissolved in the adjuvant Montanide ISA 51. Patients will be vaccinated two times with an interval of three weeks.
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)
Primary outcome measure	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	To study the clinical response to vaccination.
Overall study start date	01/11/2006
Overall study end date	01/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	10
Total final enrolment	10
Participant 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
Participant 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 patients 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
Recruitment start date	01/11/2006
Recruitment end date	01/08/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre

Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html
"ROR"	https://ror.org/05xvt9f17

Funders

Funder type

Hospital/treatment centre

Leiden University Medical Center (LUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2009	14/01/2021	Yes	No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
4. The phase has been added.