Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01617629|
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer||Biological: MUC1 Dendritic Cell Vaccine (Cvac)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
Biological: MUC1 Dendritic Cell Vaccine (Cvac)
The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).
Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year) ]An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
- Overall Survival [ Time Frame: 2 years ]Overall survival was defined as the time from randomization until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617629
|United States, California|
|Marin Cancer Care, Inc.|
|Greenbrae, California, United States, 94904|
|Scripps Cancer Center|
|La Jolla, California, United States, 92037|
|United States, Florida|
|Collaborative Research Group|
|Boca Raton, Florida, United States, 33487|
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98109|
|Greenslopes Private Hospital|
|Greenslopes, Queensland, Australia, 4120|
|Principal Investigator:||Heidy Gray, MD||University of Washington|
|Principal Investigator:||James Mason, MD||Scripps Cancer Center|
|Principal Investigator:||Peter Eisenberg, MD||Marin Cancer Care|
|Principal Investigator:||Giuseppe Del Priore, MD||Indiana University School of Medicine|
|Principal Investigator:||Fernando Recio, MD||Collaborative Research Group|
|Principal Investigator:||Jeffery Goh, MBBS, FRACP||Greenslopes Private Hospital|