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

Tracking Information

First Received Date ^ICMJE

June 8, 2012

Last Updated Date

January 14, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To evaluate the safety of Cvac administration in this population [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01617629 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epithelial Ovarian Cancer

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: Cvac Treatment Group

Patients will receive MUC1 Dendritic Cell Vaccine (Cvac) treatment.

Intervention: Biological: MUC1 Dendritic Cell Vaccine (Cvac)

Publications *

Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. Review.
Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. Review.
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.
Grossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6.
Liu PY, Alberts DS, Monk BJ, Brady M, Moon J, Markman M. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol. 2007 Aug 20;25(24):3615-20.
Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. Review.
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.
Rustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia

Administrative Information

NCT Number ^ICMJE

NCT01617629

Other Study ID Numbers ^ICMJE

CAN-003X

Has Data Monitoring Committee

Yes

Responsible Party

Prima BioMed Ltd

Study Sponsor ^ICMJE

Prima BioMed Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Prima BioMed Ltd

Verification Date

December 2012

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

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