To study (in vitro) if dendritic cells can be cultured with cells obtained from peripheral blood of patients with either m. myeloma, ovarian cancer or breast cancer. Thusfar we worked with cells from healthy volunteers. Before performing clinical…
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can we collect enough and adequate dendritic cells from the group of patients
defined above, in our facility and using our culture system.
For clarity: there will be no add back of the cells to patients in this study
Secondary outcome
not relevant.
Background summary
Since this is a local study the description in English is more limited than the
Dutch description. If a more extensive description (translation from dutch) is
necessary please let me know.
In our clinical research group the focus is on immunotherapy for blood cancers
and solid tumours, mainly breast cancer.
Development of a vaccin, using Dendritic cells, is one of the goals. We have
optimised the culture of dendritic cells in vitro and selected the system that
we want to use in vivo (Manuscript in preparation). Before performing clinical
studies using dendritic cells we have to analyse if dendritic cells obtained
from patients are equally good than the ones used from healthy volunteers thus
far (see objective of the study).
Study objective
To study (in vitro) if dendritic cells can be cultured with cells obtained from
peripheral blood of patients with either m. myeloma, ovarian cancer or breast
cancer. Thusfar we worked with cells from healthy volunteers. Before
performing clinical studies (i.e. adding back the dendritic cells to the
patient as a vaccin) we intend to study the quality of the DC obtained from
patients. Study questions are: adequate number of cells, adequate phenotype of
the DC and adequate cytokine profile of the DC.
Study design
Patients will donate blood via a leucapheresis procedure. They will have an
infusion system in both arms, one for collecting the cells and one for add back
of the blood without the leucocytes. (This leukapheresis procedure is
comparable to dialysis in kidney patients).
The procedure will take about 2 to 3 hours to collect enough cells.
The procedure is a routine procedure in the hospital for bone marrow stem cell
donors (about 80 procedures per year).
Study burden and risks
Patients will undergo a leukapheresis procedure as described above. A standard
operating procedure will be followed (protocol number AZM 15192). In case of
clinical problems (not to be expected) the procedure will be stopped. It might
be that patients with m. myeloma have had this procedure before, since it is
part of the standard treatment protocol untill a certain age to give high dose
chemotherapy and add back of stem cells. They can argue very well if they want
to perform the procedure a second time for the purpose of research only.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
patients with either breast cancer, ovarian cancer or Multiple Myeloma, that did not receive any systemic therapy during the previous three months. (Hormonal therapy is accepted in case of breast cancer). For details of inclusion: see paragraph D4b.
Exclusion criteria
Recent (3 months) systemic therapy. In more detail: see D5b.
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 | NL22622.068.08 |