Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/10/2017 |
Start Date: | December 2011 |
End Date: | April 2014 |
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
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.
cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer
eligible for study participation due to disease progression.
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
We found this trial at
6
sites
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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