The final aim of the research project is to investigate the optimal time (*window*) for vaccination after chemotherapy.• To explore the optimal time-window to start immunotherapy after chemotherapy;• To study the time-related immune response to…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The time related immune response during and after standard chemotherapy in
patients with advanced, recurrent or metastatic cervical cancer;
• The time and treatment related response to an HPV16 Synthetic Long Peptide
(SLP) immunization in cervical cancer patients, after completion of the
standard chemotherapy.
Secondary outcome
N/A
Background summary
Cervical cancer is in 60% of the cases associated with an infection with the
Human Papillomavirus (HPV). Genital human papillomavirus infection is highly
prevalent in sexually active individuals. The majority of the infected subjects
clears the infection within 1 year. In case of an persitent, uncontrolled
infection with HPV, the develment of cervical (pre) malignancies can occur.
The treament of cervical cancer depends on the stage cervical cancer.
Currently, the treatment of advanced cervical cancer mainly relies on
chemotherapy . Chemotherapeutic agents in cervical cancer kill tumor cells.
This cytotoxic effect of chemotherapy can lead to tumor regression. Considering
their toxic effect on hematopoietic cells, chemotherapy was usually considered
as immunosuppressive. In contrast, chemotherapy can also positively influence
the immune system.
Different studies suggested the possible benefit of combining chemotherapy with
immunotherapy. When combining chemotherapy with immunotherapy, timing of the
immunotherpy is likely to be crucial.
By measuring the immune response during and after chemotherapy, we will monitor
the immuno-pharmacology of chemotherapy. These measurements it is possible to
determine and evaluate whether chemotherapy can enhance vaccine induced
immunity in cases of cervical cancer.
Study objective
The final aim of the research project is to investigate the optimal time
(*window*) for vaccination after chemotherapy.
• To explore the optimal time-window to start immunotherapy after chemotherapy;
• To study the time-related immune response to standard chemotherapy in
patients with advanced, recurrent or metastatic cervical cancer using
measurements of both generic and HPV-specific immune responses;
•To study the time and treatment related response to an HPV16 Synthetic Long
Peptide (SLP) immunization in cervical cancer patients after completion of the
standard chemotherapy.
Study design
Open label, observational study
Intervention
In the second part of the study, patient will be vaccinated after completion of
the 2nd cycle of chemotherapy. Further chemotherapeutic treatment will continue
according to the oncology protocol.
Study burden and risks
In the first cohort, six patients will be treated with the standard
chemotherapy for the treatment of advanced cervical cancer. This means that
patients that do not want to participate in this study, will be treated with
the same chemotherapy.
In case of participation, additional blood samples will be collected.
Bloodsampling will be combined as much as possible with standard and routine
bloodsampling (because of chemotherapeutic treatment) and with hospital visits.
In het second cohort, during chemotherapy, additional immunotherapy with
vaccination with HPV-SLP vaccin will take place once in twelve patients. A
phase I clinical vaccination study was performed in patients with end-stage
cervical cancer. The HPV16-SLP vaccine was administered weekly 4 times at
weekly intervals. This vaccine was well tolerated. Vaccination was mostly
accompanied with local pain, redness and swelling of the local skin, some cases
of passing fever where reported. In previous vaccination trials, some patients
had an allergisch reaction to vaccination. This reaction included itchiness,
swelling of lips/eyelids and sporadically shortness of breath. Additional
safety and emergency measurements will be done in order to prevent/treat
allergic reactions.
Albinusdreef 2; Postbus 9600
2300 RC Leiden
NL
Albinusdreef 2; Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
- Patients should be at least 18 years of age;
- Patients should be able and willing to provide informed consent;
- Patients with a diagnosis of histologically confirmed cervical cancer that is clinically and/or radiologically proven advanced, recurrent or metastatic for whom no curative treatment (surgery or radiotherapy) options are available;
- Patients scheduled for standard chemotherapy with Carboplatin / Paclitaxel;
Exclusion criteria
For all patients (first and second cohort) the following exclusion criteria apply:
- Any condition that in the opinion of the treating physician(s) is likely to jeopardise the well-being of health status of the patient;
- Another active malignancy
- Positive test result for HIV
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-018841-76-NL |
| CCMO | NL31572.000.10 |