Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd
ClinicalTrials.gov Identifier:
NCT01617629
First received: June 8, 2012
Last updated: July 17, 2013
Last verified: July 2013

June 8, 2012
July 17, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
Safety will be measured through review of the number and type of adverse events associated with Cvac at all timepoints for each patient and across patients. [ Time Frame: 1 Year of active dosing ] [ Designated as safety issue: No ]
To evaluate the safety of Cvac administration in this population [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01617629 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
For eligible patients that have completed or terminated the study, the collection of Overall Survival data will continue through October 2015.
Not Provided
 
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epithelial Ovarian Cancer
Biological: MUC1 Dendritic Cell Vaccine (Cvac)

The recommended dosing regimen for CAN-003X is 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).

Patients who received more than 3 doses of Cvac in CAN-003 should continue 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)

Experimental: Cvac Treatment Group
Patients will receive MUC1 Dendritic Cell Vaccine (Cvac) treatment.
Intervention: Biological: MUC1 Dendritic Cell Vaccine (Cvac)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
December 2013
December 2013   (final data collection date for primary outcome measure)

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 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/mm3

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01617629
CAN-003X
Yes
Prima BioMed Ltd
Prima BioMed Ltd
Not Provided
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 Simon Cancer Center
Principal Investigator: Fernando Recio, MD Collaborative Research Group
Principal Investigator: Jeffery Goh, MBBS, FRACP Greenslopes Private Hospital
Prima BioMed Ltd
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP