Condition category
Cancer
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
16/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F M Speetjens

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 2857
f.m.speetjens@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P06.019

Study information

Scientific title

Acronym

p53

Study hypothesis

p53 mutation in colorectal cancer provides an immunological window for immune therapy.

Ethics approval

Approval received from the Committee Medical Ethics, Leiden University Medical Center, on April 13 2006 (ref: P06.019).

Study design

Non-randomised clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Drug

Phase

Phase I

Drug names

p53 peptides

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

01/08/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

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 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

Recruitment start date

01/11/2006

Recruitment end date

01/08/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Center (LUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes