Trial Outcomes & Findings for Pilot Study of GVAX in Colorectal Cancer Cells (NCT NCT01952730)

NCT ID: NCT01952730

Last Updated: 2023-01-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2023-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Treatment Arm GVAX, up to 6 vaccinations, administered via injection GVAX
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Treatment Arm GVAX, up to 6 vaccinations, administered via injection GVAX
Overall Study FDA shut down core lab used by study	1

Baseline Characteristics

Pilot Study of GVAX in Colorectal Cancer Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Treatment Arm n=1 Participants GVAX, up to 6 vaccinations, administered via injection GVAX
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Experimental Treatment Arm n=1 Participants GVAX, up to 6 vaccinations, administered via injection GVAX
Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity	0 participants

SECONDARY outcome

Timeframe: 75 months

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.

Outcome measures

Outcome measures
Measure	Experimental Treatment Arm n=1 Participants GVAX, up to 6 vaccinations, administered via injection GVAX
Progression Free Survival	75 months

SECONDARY outcome

Timeframe: 2 years

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

To assess overall survival at 2 years

Outcome measures

Outcome measures
Measure	Experimental Treatment Arm n=1 Participants GVAX, up to 6 vaccinations, administered via injection GVAX
Two Year Survival	1 Participants

Adverse Events

Experimental Treatment Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Treatment Arm n=1 participants at risk GVAX, up to 6 vaccinations, administered via injection GVAX
Gastrointestinal disorders Diarrhea	100.0% 1/1 • 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.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • 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.
General disorders Fatigue	100.0% 1/1 • 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.

Additional Information

Cristina R. Ferrone, MD

Massachusetts General Hospital

Phone: 617-643-6189

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place