Primary objective; Ex vivo charting of T cell reactivity directed against the tumour antigen survivin in peripheral blood of HNSCC patients. Secondary objective; Ex vivo charting of T cell reactivity against tumour antigens other than survivin.…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary; Charting the presence of tumour specific T cells will be performed
employing tetramer staining. In house made HLA-A1 and HLA-A2 tetramers will be
used to detect T cells directed against known antigenic peptide sequences
derived from the tumour antigen survivin. This will document the presence of T
cells with such specificities as a percentage of total CD8 positive T cells. It
is expected that in about half of the patients survivin specific T cells will
be detectable.
Secondary outcome
Secondary; Since tetramers are available containing antigenic peptides derived
from tumour antigens other than survivin, it is possible to chart the immune
reactivity against these antigens simultaneously. We will do so employing
tetramers with a fluorescent marker different form the one used for survivin.
Tertiary; Tetramer positive T cells will be isolated from these samples when
possible.
Background summary
Cancer specific T cell reactivity can aid substantially in the destruction of
growing tumours and distant metastasis. Potentiating the efficacy of such T
cell reactivity can be achieved by vaccination of cancer patients with
(autologous) dendritic cells loaded with immunogenic tumour antigens. Charting
naturally occurring T cell reactivity against predefined tumour antigen(s) in
HNSCC patients will help in the design of a potent dendritic cell based
vaccine. Peripheral blood can be used as a source of such T cells, this does
not interfere with diagnosis or treatment outcome.
Study objective
Primary objective; Ex vivo charting of T cell reactivity directed against the
tumour antigen survivin in peripheral blood of HNSCC patients. Secondary
objective; Ex vivo charting of T cell reactivity against tumour antigens other
than survivin. Tertiary objective; Isolation of tumour specific T cells from
the same samples.
Study design
This is an observational study from which the participating patients will not
benefit. Peripheral blood will be drawn just once and some time after the
patients have received standard treatment. Prior treatment can consist of
surgery, radiotherapy and/or chemotherapy. In order not to interfere with these
treatments blood will not be drawn before treatment. In case the patient also
received chemotherapy a period of rest will be observed for the immune system
to recover.
Study burden and risks
Patients will be asked to donate a single blood sample of 120 ml. The blood
sample will be collected using a butterfly needle in order to minimize the
burden of changing heparin containing vacuum tubes.
de Boelelaan 1117
1081 HV Amsterdam
Nederland
de Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
The patients in this study must have a histological confirmation of Head and Neck carcinoma stage 3 or higher.
Patients must be over 18 years of age. There is no maximum age.
Patients must be capable of giving informed consent.
Patients must have a life expectancy of at least 3 months.
Patients must be HLA-A2 positive.
Exclusion criteria
Patients are excluded when pregnant.
Patients are excluded when anemic.
Design
Recruitment
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 |
|---|---|
| CCMO | NL28567.029.09 |