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
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This study is a Pilot clinical trial. Pilot clinical trials test the safety of an investigational combination of drugs. Pilot studies provide information on what effects, both good and bad, the Investigational agent might have on your disease. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved the treatment for your type of cancer.
The main purposes of this study are to determine:
- The amount of vaccine that can be made for your colorectal tumor cells
- If the vaccine can be given safely
- What the effects of the vaccine are, both good and bad
- How the vaccine affects your immune system
- Whether this vaccine might have any effect on the return of your cancer in the liver after surgical removal
This study is being done because there are currently no treatments which have demonstrated to cure diseae which has progressed, or moved beyond the site of the primary site of disease (colon or rectum). These vaccinations will be given after you have completed the standard of care treatment as determined by your doctor.
Laboratory research has made vaccines from cancer cells by inserting genetic material from a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The vaccine made form these cells has a greater anti-tumor effect than cancer cells without GM-CSF. The purpose of this research study is to determine the safety of an investigational vaccine that will be made using your own colorectal cancer cells in the manner described above.
This vaccine has been used in several other research studies for treatment for other cancers (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies suggests that this vaccine may help to reduce the risk of your colorectal cancer returning after you have your colorectal cancer surgery.
Due to these results in melanoma and several other tumors we are encouraged to use this vaccine approach in patients with liver metastases from colorectal cancer, after the cancer in the liver has been removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: GVAX||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Safety Study of Vaccination With Autologous, Lethally Irradiated Colorectal Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor|
|Actual Study Start Date :||November 8, 2013|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||February 2020|
Experimental: Experimental Treatment Arm
GVAX, up to 6 vaccinations, administered via injection
- Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity [ Time Frame: 2 years ]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.
- Progression Free Survival [ Time Frame: 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.
- Immune Response [ Time Frame: 2 years ]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.
- Two Year Survival [ Time Frame: 2 years ]To assess overall survival at 2 years
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically documented hepatic colorectal cancer metastasis with resectable hepatic lesions
- At least 4 weeks since last dose of chemotherapy, radiotherapy, immunotherapy, systemic glucocorticoid therapy or operation in order to receive vaccine
- Fully recovered from hepatic resection
- Pregnant or breastfeeding
- Uncontrolled active infection
- Infection with HIV, Hepatitis B or C
- Other current malignancies except in situ cancer or basal/squamous cell carcinoma
- Active autoimmune disease
- Hepatic metastases involving both branches of the portal vein or all three hepatic veins
- Peritoneal metastases identified at the time of attempted resection
- Greater than 1 month since resection of liver metastasis for vaccine production
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952730
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Cristina Ferrone, MD||Massachusetts General Hospital|
Documents provided by Cristina R. Ferrone, MD, Massachusetts General Hospital:
|Responsible Party:||Cristina R. Ferrone, MD, Principal Investigator, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||September 30, 2013 Key Record Dates|
|Results First Posted:||January 12, 2023|
|Last Update Posted:||January 12, 2023|
|Last Verified:||December 2022|
Digestive System Neoplasms
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Digestive System Diseases