Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod
- Patients must have undergone therapeutic debulking surgery for independent clinical
indications and have tissue frozen and stored under sterile conditions as part of
protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a
Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal
Cancer)
- Participants will be assigned to one of two study groups. Both groups will undergo a
procedure known as leukapheresis by which the white blood cells are removed from the
participants blood in order to obtain the dendritic cells. Prior to this procedure
participants may receive 4 injections of GM-CSF, which helps increase the white blood
cell count.
- If enough cells are obtained during the leukapheresis, tumor cells and dendritic cells
will then be fused (mixed) together in the laboratory and divided into the appropriate
doses for administration.
- Participants assigned to Group 1 will undergo subcutaneous vaccination with the
dendritic cell tumor fusion vaccine. On the day of the vaccine and three days
afterwards, they will receive GM-CSF injections at the site of the vaccination.
Participants will receive a dose of the vaccine every 3 weeks for a total of 3
vaccinations.
- Participants assigned to Group 2 will undergo subcutaneous vaccination with the
dendritic cell tumor fusion vaccine. On the day of the vaccine and three days
afterwards, they will receive GM-CSF injection at the site of the vaccination.
Additionally, imiquimod cream will be applied to the skin at the injection sight 2
hours before the vaccine administration. Participants will continue to apply imiquimod
cream at the site of vaccination for 3 days following the injection. Participants will
receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.
2 years
No
David Avigan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
07-380
NCT00799110
August 2008
June 2013
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Brigham & Women's Hospital | Boston, Massachusetts 02115 |