Trial ID or NCT#

NCT01521143

Status

not recruiting iconNOT RECRUITING

Purpose

As < 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of < 10%. The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.

Official Title

A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-glutathione S-transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients With Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-line Chemotherapy (A) and Patients With EOC in Second Remission (B)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc
Gynecologic oncologist
Laurie Kraus Lacob Professor
Nelson Teng
Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.
Gynecologic oncologist, Medical oncologist, Gynecologic oncologist
Associate Professor of Obstetrics and Gynecology (Oncology)

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CONTACT

Cancer Clinical Trials Office
(650) 498-7061