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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 : May 1, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

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.


Participant Flow:   Overall Study
    Vigil™ Vaccine
STARTED   5 
COMPLETED   2 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Disease Progression                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

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.


Baseline Measures
   Vigil™ Vaccine 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age, Customized 
[Units: Participants]
Count of Participants
 
Age   
0-15 Years      0   0.0% 
16-64 Years      3  60.0% 
65 Years and Older      2  40.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White/Caucasian   5 
Black/African American   0 
Asian   0 
Hispanic   0 
Other   0 


  Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: 24 months ]

2.  Primary:   Response Rate   [ Time Frame: Up to 12 months ]

3.  Secondary:   Number of Alive Subjects   [ Time Frame: 24 months ]

4.  Secondary:   Immune Analysis in Blood   [ Time Frame: Up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Director of Clinical Trials
Organization: Gradalis, Inc.
phone: 2144428124
e-mail: info@gradalisinc.com


Publications:

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: May 1, 2018