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

Prima BioMed

Status and phase

Completed

Phase 2

Conditions

Epithelial Ovarian Cancer

Treatments

Biological: MUC1 Dendritic Cell Vaccine (Cvac)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01617629

CAN-003X

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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