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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
Time to Progression
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.
Time frame: 24 months
Response Rate
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Time frame: Up to 12 months
Number of Alive Subjects
Survival status of patients after treatment was determined by following these patients up to 24 months.
Time frame: 24 months
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
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.
Time frame: Baseline, End of Treatment (30 days after last dose) up to 12 months
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