Clinical trial NCT01617629: Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Keywords: Cvac
Lead sponsor: Prima BioMed Ltd
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
Secondary outcomes:
Other outcomes:
measure: Overall Survival
timeFrame: 2 years
Locations:
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc.
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Boca Raton
country: United States
facility: Collaborative Research Group
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
Study officials:
affiliation: University of Washington
name: Heidy Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Cancer Center
name: James Mason, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marin Cancer Care
name: Peter Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Giuseppe Del Priore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Collaborative Research Group
name: Fernando Recio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Greenslopes Private Hospital
name: Jeffery Goh, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
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