Spots Global Cancer Trial Database for Ovarian Cancer Vaccine for Patients in Remission
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Trial Identification
Brief Title: Ovarian Cancer Vaccine for Patients in Remission
Official Title: A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission
Study ID: NCT01068509
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning. Study objectives Primary objectives: * To confirm the safety of administering Cvac in this population. * To determine the effects of Cvac on progression-free survival (PFS). Secondary objectives: * To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting. * Evaluation of host immunologic response to Cvac administration.
Detailed Description: An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Marin Cancer Care, Inc., Greenbrae, California, United States
Scripps Cancer Center, La Jolla, California, United States
Stanford University School of Medicine, Palo Alto, California, United States
University of California, San Francisco, San Francisco, California, United States
Collaborative Research Group, Boca Raton, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
Morristown Medical Center, Morristown, New Jersey, United States
New York Downtown Hospital, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
University of Washington Medical Center, Seattle, Washington, United States
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Gold Coast Hospital, Southport, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Cetnre, East Melbourne, Victoria, Australia
Austin Health Cancer Centre, Heidelberg, Victoria, Australia
Contact Details
Name: Heidi Gray, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Moradi, MD
Affiliation: New York Presbyterian Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jonathan Berek, MD, MMS
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
Name: Nana Tchabo, MD
Affiliation: Morristown Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jennifer Young, MD
Affiliation: Medical University of South Carolina
Role: PRINCIPAL_INVESTIGATOR
Name: James Mason, MD
Affiliation: Scripps Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Angeles Secord, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Eisenberg, MD
Affiliation: Marin Cancer Care
Role: PRINCIPAL_INVESTIGATOR
Name: Giuseppe Del Priore, MD
Affiliation: Indiana University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Rose, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Fernando Recio, MD
Affiliation: Collaborative Research Group
Role: PRINCIPAL_INVESTIGATOR
Name: Benedict Benigno, MD
Affiliation: Northside Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: John Chan, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR
Name: Paul Mitchell, MB ChB
Affiliation: Austin Health Cancer Care
Role: PRINCIPAL_INVESTIGATOR
Name: Linda Mileshkin, MBBS
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: Margaret Davy, MBBS, CGO
Affiliation: Royal Adelaide Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Goh, MBBS, FRACP
Affiliation: Greenslopes Private Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Marco Matos, FRACP
Affiliation: Gold Coast Hospital
Role: PRINCIPAL_INVESTIGATOR
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