Back to resultsOvarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)
Primary Purpose
Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MUC1 Dendritic Cell Vaccine (Cvac)
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Cvac
Eligibility Criteria
Inclusion Criteria:
- Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
- Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
- Were enrolled in CAN-003 and met protocol criteria for progressive disease
- Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
- Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
- Able to provide written informed consent
- White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3
Exclusion Criteria:
- Pregnant or breastfeeding
- Other medical conditions which preclude study participation, in the opinion of the investigator
- Receiving treatment with any other investigational product
Sites / Locations
- Marin Cancer Care, Inc.
- Scripps Cancer Center
- Collaborative Research Group
- Indiana University Simon Cancer Center
- University of Washington Medical Center
- Greenslopes Private Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cvac Treatment Group
Arm Description
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01617629
Brief Title
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Acronym
CAN-003X
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 Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prima BioMed Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
Cvac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cvac Treatment Group
Arm Type
Experimental
Arm Description
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
Intervention Type
Biological
Intervention Name(s)
MUC1 Dendritic Cell Vaccine (Cvac)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Description
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.
Time Frame
First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
Other Pre-specified Outcome Measures:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization until death from any cause.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
Were enrolled in CAN-003 and met protocol criteria for progressive disease
Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
Able to provide written informed consent
White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3
Exclusion Criteria:
Pregnant or breastfeeding
Other medical conditions which preclude study participation, in the opinion of the investigator
Receiving treatment with any other investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidy Gray, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Mason, MD
Organizational Affiliation
Scripps Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Eisenberg, MD
Organizational Affiliation
Marin Cancer Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Del Priore, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Recio, MD
Organizational Affiliation
Collaborative Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffery Goh, MBBS, FRACP
Organizational Affiliation
Greenslopes Private Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marin Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Collaborative Research Group
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
7538768
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
Desai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).
Results Reference
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PubMed Identifier
9548459
Citation
Apostolopoulos V, Karanikas V, Haurum JS, McKenzie IF. Induction of HLA-A2-restricted CTLs to the mucin 1 human breast cancer antigen. J Immunol. 1997 Dec 1;159(11):5211-8.
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PubMed Identifier
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Citation
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PubMed Identifier
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Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
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PubMed Identifier
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PubMed Identifier
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Citation
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Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
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