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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: January 14, 2013
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Epithelial Ovarian Cancer
 Biological: MUC1 Dendritic Cell Vaccine (Cvac)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prima BioMed Ltd:

Primary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cvac Treatment Group
Patients will receive MUC1 Dendritic Cell Vaccine (Cvac) treatment.
 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617629

Locations
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
Investigators
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
  More Information

Additional Information:
Related Info from Sponsor's Web Site  This link exits the ClinicalTrials.gov site

Publications:
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.

Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01617629     History of Changes
Other Study ID Numbers: CAN-003X
Study First Received: June 8, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Prima BioMed Ltd:
Cvac

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2013