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

Epithelial Ovarian Cancer Clinical Trial

— CAN-003X  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617629
• Other study ID #: CAN-003X
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: November 10, 2017
• Start date: December 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2017
• Source: Prima BioMed Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
United States	Collaborative Research Group	Boca Raton	Florida
United States	Marin Cancer Care, Inc.	Greenbrae	California
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Scripps Cancer Center	La Jolla	California
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Prima BioMed Ltd

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (10)

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. — View Citation

Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. Review. — View Citation

Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. Review. — View Citation

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).

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. — View Citation

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. — View Citation

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. — View Citation

Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	Overall survival was defined as the time from randomization until death from any cause.	2 years
Primary	Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	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.	First dose of study vaccine to 30 days past last dose (Approximately 1 Year)

External Links

•   Related Info from Sponsor's Web Site