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Pilot Study of GVAX in Colorectal Cancer Cells

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: NCT01952730
Recruitment Status : Terminated (Slow Accrual)
First Posted : September 30, 2013
Results First Posted : January 12, 2023
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Cristina R. Ferrone, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Colorectal Cancer
Intervention Biological: GVAX
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description

GVAX, up to 6 vaccinations, administered via injection

GVAX
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
FDA shut down core lab used by study             1
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description

GVAX, up to 6 vaccinations, administered via injection

GVAX
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity
Hide Description To determine the safety of 6 vaccinations with lethally irradiated, autologous colorectal cancer cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in stage IV colorectal cancer patients who are completely resected. Patient safety will be assured by monitoring the number of patients who fail to receive the first six scheduled vaccinations because of toxicity. If three or more patients experience grade 4 or worse toxicity due to the vaccine before completing six immunizations, the study will be terminated.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description:

GVAX, up to 6 vaccinations, administered via injection

GVAX
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Progression Free Survival
Hide Description To determine the progression free survival of stage IV colorectal cancer patients vaccinated with lethally irradiated, autologous colorectal cancer cells engineered by adenoviral mediated gene transfer to secrete GM-CSF. Progression-Free Survival (PFS) is defined as the length of time during and after the treatment of a cancer, that a patient lives with the disease but it does not get worse, as per the National Cancer Institute. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 75 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description:

GVAX, up to 6 vaccinations, administered via injection

GVAX
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: months
75
3.Secondary Outcome
Title Immune Response
Hide Description To evaluate the immune response elicited by the vaccine. We will evaluate the immune cell composition(CD4+ and CD8+ T cells, T regulatory cells, macrophage, etc) in the resected specimens and in the circulating blood.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was registered to this study who failed to receive all 6 vaccinations cause FDA put a few studies on hold since the core lab used by the studies was shut down by FDA. This study did not continue to draw blood so not enough data was collected to perform analysis.
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description:

GVAX, up to 6 vaccinations, administered via injection

GVAX
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Two Year Survival
Hide Description To assess overall survival at 2 years
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description:

GVAX, up to 6 vaccinations, administered via injection

GVAX
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame All adverse events experienced by participants will be collected from the time of the first vaccine administration, through the study and until the final study visit. Total time frame is approximately 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Treatment Arm
Hide Arm/Group Description

GVAX, up to 6 vaccinations, administered via injection

GVAX
All-Cause Mortality
Experimental Treatment Arm
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
Experimental Treatment Arm
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Treatment Arm
Affected / at Risk (%)
Total   1/1 (100.00%) 
Gastrointestinal disorders   
Diarrhea † 1  1/1 (100.00%) 
Abdominal pain † 1  1/1 (100.00%) 
General disorders   
Fatigue † 1  1/1 (100.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cristina R. Ferrone, MD
Organization: Massachusetts General Hospital
Phone: 617-643-6189
EMail: CFERRONE@PARTNERS.ORG
Layout table for additonal information
Responsible Party: Cristina R. Ferrone, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01952730    
Other Study ID Numbers: 12-436
First Submitted: April 26, 2013
First Posted: September 30, 2013
Results First Submitted: September 1, 2021
Results First Posted: January 12, 2023
Last Update Posted: January 12, 2023