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| Sponsor: | Prima BioMed Ltd |
|---|---|
| Collaborators: |
SPRI Clinical Trials Global, LLC Sciformix Technologies Private Limited CPR Pharma Services Pty Ltd Progenitor Cell Therapy LLC Cell Therapies Pty Ltd |
| Information provided by: | Prima BioMed Ltd |
| ClinicalTrials.gov Identifier: | NCT01068509 |
Purpose
The purpose of this study is to determine the safety and efficacy of an investigational vaccine in ovarian cancer patients in remission and to determine its ability to prevent cancer from returning.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer |
Biological: MUC1 Dendritic Cell Vaccine (Cvac) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment group
Patients will be receiving MUC1 Dendritic Cell Vaccine (Cvac) treatment.
|
Biological: MUC1 Dendritic Cell Vaccine (Cvac)
Patients will receive vaccinations every four weeks for 24 weeks followed by injections every eight weeks for an additional 24 weeks.
Other Name: Cvac
|
|
No Intervention: Standard of care
Patients will be under observation, no cancer treatment will be given to this group.
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STUDY OBJECTIVES:
The purpose of this trial is to determine the safety and efficacy of Cvac compared with Standard of Care in ovarian cancer patients who are in remission after first or second-line therapy.
Primary Objectives:
Secondary Objectives:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Marin Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Scripps Cancer Center | |
| La Jolla, California, United States, 92037 | |
| Stanford University | |
| Palo Alto, California, United States, 94305 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Collaborative Research Group | |
| Boynton Beach, Florida, United States, 33435 | |
| United States, Georgia | |
| Northside Hospital | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New Jersey | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| New York Downtown Hospital | |
| New York, New York, United States, 10038 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98109 | |
| Australia, Queensland | |
| Greenslopes Private Hospital | |
| Greenslopes, Queensland, Australia, 4120 | |
| Gold Coast Hospital | |
| Southport, Queensland, Australia, 4215 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Cetnre | |
| East Melbourne, Victoria, Australia, 3002 | |
| Austin Health | |
| Heidelberg, Victoria, Australia, 3084 | |
| Principal Investigator: | Heidi Gray, MD | University of Washington |
| Principal Investigator: | Joseph Bottino, MD | New York Downtown Hospital |
| Principal Investigator: | Jonathan Berek, MD, MMS | Stanford University |
| Principal Investigator: | Nana Tchabo, MD | Morristown Memorial Hospital |
| Principal Investigator: | Jennifer Young, MD | Medical University of South Carolina |
| Principal Investigator: | James Mason, MD | Scripps Cancer Center |
| Principal Investigator: | Angeles Secord, MD | Duke University |
| Principal Investigator: | Peter Eisenberg, MD | California Cancer Care, Inc. |
| Principal Investigator: | Giuseppe Del Priore, MD | Indiana University Simon Cancer Center |
| Principal Investigator: | Peter Rose, MD | The Cleveland Clinic |
| Principal Investigator: | Fernando Recio, MD | Collaborative Research Group |
| Principal Investigator: | Benedict Benigno, MD | Northside Hospital |
| Principal Investigator: | John Chan, MD | University of California, San Francisco |
| Principal Investigator: | Paul Mitchell, MB ChB | Austin Health |
| Principal Investigator: | Linda Mileshkin, MBBS | Peter MacCallum Cancer Centre, Australia |
| Principal Investigator: | Margaret Davy, MBBS, CGO | Royal Adelaide Hospital |
| Principal Investigator: | Jeffrey Goh, MBBS, FRACP | Greenslopes Private Hospital |
| Principal Investigator: | Marco Matos, FRACP | Gold Coast Hospital |
More Information
| Responsible Party: | Neil Frazer/Chief Medical Officer, Prima BioMed Ltd |
| ClinicalTrials.gov Identifier: | NCT01068509 History of Changes |
| Other Study ID Numbers: | CAN-003 |
| Study First Received: | February 10, 2010 |
| Last Updated: | September 16, 2011 |
| Health Authority: | United States: Food and Drug Administration; Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council |
|
CVac |
|
Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |