Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
NCT ID: NCT01617629
Last Updated: 2017-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2011-12-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Other medical conditions which preclude study participation, in the opinion of the investigator
* Receiving treatment with any other investigational product
18 Years
FEMALE
No
Sponsors
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Prima BioMed Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Heidy Gray, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
James Mason, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Cancer Center
Peter Eisenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Marin Cancer Care
Giuseppe Del Priore, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Fernando Recio, MD
Role: PRINCIPAL_INVESTIGATOR
Collaborative Research Group
Jeffery Goh, MBBS, FRACP
Role: PRINCIPAL_INVESTIGATOR
Greenslopes Private Hospital
Locations
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Marin Cancer Care, Inc.
Greenbrae, California, United States
Scripps Cancer Center
La Jolla, California, United States
Collaborative Research Group
Boca Raton, Florida, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
University of Washington Medical Center
Seattle, Washington, United States
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Countries
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References
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Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. doi: 10.1615/critrevimmunol.v14.i3-4.40.
Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. doi: 10.1038/icb.1996.76.
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).
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. doi: 10.5694/j.1326-5377.2002.tb04616.x.
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
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. doi: 10.1200/JCO.2006.09.4540.
Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. doi: 10.1054/bjoc.2000.1174.
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. doi: 10.1200/JCO.2000.18.8.1733.
Related Links
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Related Info from Sponsor's Web Site
Other Identifiers
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CAN-003X
Identifier Type: -
Identifier Source: org_study_id