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Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod
This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.
* 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Start Date
August 1, 2008
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
June 11, 2024
23
ESTIMATED participants
GM-CSF
DRUG
Dendritic Cell/Tumor Fusion Vaccine
BIOLOGICAL
imiquimod
DRUG
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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