Clinical Trial: Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
Brief Summary: The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together
Detailed Summary:
Approximately 600 million people worldwide are infected with the Human Papilloma Virus. In the majority of cases people can clear the virus on their own however in cases where the infection is not recognized or is left untreated, the result can be cervical cancer.
This study will examine the safety and tolerability of Hsp-E7 and Poly-ICLC administered together as a vaccine for Cervical Intraepithelial neoplasia (CIN). There will be 4 cohorts of subjects in the study each given a higher dose than the one prior providing that prior dose has been well tolerated and deemed to be safe.
Subjects will be immunized every 28 days for a period of 8 weeks (3 administrations).
Posttreatment evaluation will occur 4 weeks after the last of 3 injections. Subjects with CIN 2 or 3 disease at the time of enrollment will be eligible to undergo clinically appropriate therapeutic treatment of the cervix at the twelfth of the study.
Sponsor: Nventa Biopharmaceuticals Corporation
Current Primary Outcome: Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia [ Time Frame: 4 Weeks after the last of 3 Injections ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia [ Time Frame: 4 Weeks after the last of 3 Injections ]
Original Secondary Outcome: Same as current
Information By: Nventa Biopharmaceuticals Corporation
Dates:
Date Received: June 26, 2007
Date Started: May 2007
Date Completion: June 2008
Last Updated: May 5, 2008
Last Verified: May 2008
