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Trial record 2 of 14 for:    22186789 [PUBMED-IDS]

Salvage Ovarian FANG™ Vaccine + Bevacizumab

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ClinicalTrials.gov Identifier: NCT01551745
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : May 1, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Interventions Biological: Vigil™ Vaccine
Drug: Bevacizumab
Enrollment 5
Recruitment Details This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).
Pre-assignment Details 5 subjects were enrolled and started Vigil treatment plus Bevacizumab. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1).
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Period Title: Overall Study
Started 5
Completed 2 [1]
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Disease Progression             2
[1]
"Completed" means subject had been given all manufactured doses
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 5 participants
0-15 Years
0
   0.0%
16-64 Years
3
  60.0%
65 Years and Older
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
White/Caucasian
5
 100.0%
Black/African American
0
   0.0%
Asian
0
   0.0%
Hispanic
0
   0.0%
Other
0
   0.0%
1.Primary Outcome
Title Time to Progression
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Response Rate
Hide Description Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Alive Subjects
Hide Description Survival status of patients after treatment was determined by following these patients up to 24 months.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 24 months, only 1 of the 5 subjects was alive. Statistical analysis was not done. This study was terminated.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Alive Subjects After 24 months
1
  20.0%
Dead Subjects After 24 months
4
  80.0%
4.Secondary Outcome
Title Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 12 months, all 5 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
ELISPOT-Positive After 12 months
5
 100.0%
ELISPOT-Negative After 12 months
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

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).

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).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

All-Cause Mortality
Vigil™ Vaccine
Affected / at Risk (%)
Total   4/5 (80.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vigil™ Vaccine
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Hepatobiliary disorders   
Acute Cholecystitis  1  1/5 (20.00%)  1
Infections and infestations   
Pharyngitis  1  1/5 (20.00%)  1
Nervous system disorders   
Intracerebral Hemorrhage  1  1/5 (20.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vigil™ Vaccine
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
General disorders   
Injection Site Reaction  1  2/5 (40.00%)  33
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Gradalis, Inc.
Phone: 2144428124
EMail: info@gradalisinc.com
Layout table for additonal information
Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01551745     History of Changes
Other Study ID Numbers: CL-PTL 112
First Submitted: March 1, 2012
First Posted: March 13, 2012
Results First Submitted: February 15, 2018
Results First Posted: May 1, 2018
Last Update Posted: August 7, 2019