p53 immunotherapy in patients treated for metastasised colorectal cancer
| ISRCTN | ISRCTN43704292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43704292 |
| Protocol serial number | P06.019, NL793, NTR806 |
| Sponsor | Leiden University Medical Center (LUMC) (The Netherlands) |
| Funder | Leiden University Medical Center (LUMC) (The Netherlands) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr F M Speetjens
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Surgical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 2857 |
|---|---|
| f.m.speetjens@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised clinical trial |
| Secondary study design | Single-centre |
| Scientific title | p53 immunotherapy in patients treated for metastasised colorectal cancer |
| Study acronym | p53 |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
To define safety and immunogenicity of a p53 specific vaccine in combination with a defined adjuvant in patients treated for metastasised colorectal cancer. |
| Key secondary outcome measure(s) |
To study the clinical response to vaccination. |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
