We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01617629
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Prima BioMed Ltd

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Biological: MUC1 Dendritic Cell Vaccine (Cvac) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
Biological: MUC1 Dendritic Cell Vaccine (Cvac)

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 Measures :
  1. Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year) ]
    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.

Other Outcome Measures:
  1. Overall Survival [ Time Frame: 2 years ]
    Overall survival was defined as the time from randomization until death from any cause.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617629

Layout table for location information
United States, California
Marin Cancer Care, Inc.
Greenbrae, California, United States, 94904
Scripps Cancer Center
La Jolla, California, United States, 92037
United States, Florida
Collaborative Research Group
Boca Raton, Florida, United States, 33487
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98109
Australia, Queensland
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Sponsors and Collaborators
Prima BioMed Ltd
Layout table for investigator information
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 School of Medicine
Principal Investigator: Fernando Recio, MD Collaborative Research Group
Principal Investigator: Jeffery Goh, MBBS, FRACP Greenslopes Private Hospital
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).
Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.

Layout table for additonal information
Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01617629    
Other Study ID Numbers: CAN-003X
First Posted: June 12, 2012    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017
Last Verified: November 2017
Keywords provided by Prima BioMed Ltd:
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type