Salvage Ovarian FANG™ Vaccine + Bevacizumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01551745|
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : May 1, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage III Ovarian Cancer Stage IV Ovarian Cancer||Biological: Vigil™ Vaccine Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Vigil™ Vaccine
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).
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).
Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Other Name: VEGF
- Time to Progression [ Time Frame: 24 months ]Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
- Response Rate [ Time Frame: Up to 12 months ]Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
- Number of Alive Subjects [ Time Frame: 24 months ]Survival status of patients after treatment was determined by following these patients up to 24 months.
- Enzyme-Linked ImmunoSorbent Spot (ELISPOT) [ Time Frame: Baseline, End of Treatment (30 days after last dose) up to 12 months ]To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551745
|United States, Texas|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||Minal Barve, MD||Mary Crowley Cancer Research Centers|