NCT01551745

Salvage Ovarian FANG™ Vaccine + Bevacizumab

Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Bevacizumab for Patients With Recurrent/Refractory Ovarian Cancer Participating in Study CL-PTL 105

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Gradalis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Conditions

• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Vigil™ Vaccine	Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
DRUG	Bevacizumab	Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-03-13
• Last updated: 2021-10-19
• Results posted: 2018-05-01

Locations

1 site across 1 country: United States