A variation to the Cvac phase 2b trial has been listed on the clinicaltrials.gov website.
The original 2b trial is code CAN-003. This is listed as trial CAN-003X.
It is a trial aimed at assessing “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.”
This is the first indication I have seen from any source that there may have been progression among some members of the 2b trial Cvac group. It could also be in anticipation of that unfortunate occurence.
I am confused by the numbers though. The 2b trial enrolled 45-48 patients in the Cvac arm and 15 in the control (current standard of care) group. This new trial has an estimated enrolment of 15.
Very interested to hear the interpretation of others re the significance of this trial.
Please note the following is NOT the complete document.
The full document is available at this link: http://clinicaltrials.gov/ct2/show/NCT01617629?term=cancer&rcv_d=14
........................................................... "Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)
This study is enrolling participants by invitation only.
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
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
Further study details as provided by Prima BioMed Ltd:
Primary Outcome Measures: • To evaluate the safety of Cvac administration in this population [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 15 Study Start Date: April 2011 Estimated Study Completion Date: February 2014 Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms: Experimental: Cvac Treatment Group Patients will receive MUC1 Dendritic Cell Vaccine (Cvac) treatment.
Assigned Interventions ; Biological: MUC1 Dendritic Cell Vaccine (Cvac) Patients enrolled in the Cvac arm of CAN-003 and who progressed prior to the fourth dose of Cvac will receive Cvac monthly for the first 3 doses and subsequently every 12 weeks. Patients who received more than 3 doses of Cvac in CAN-003 should continue with dosing in CAN-003 where they left off at the time of progression, and any subsequent doses will be given every 12 weeks for up to one year.
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 leukapheresis (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
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