Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GVAX for Colorectal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01952730
Recruitment Status : Recruiting
First Posted : September 30, 2013
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Cristina R. Ferrone, MD, Massachusetts General Hospital

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2030

Arm Intervention/treatment
Experimental: Experimental Treatment Arm
GVAX, up to 6 vaccinations, administered via injection
Biological: GVAX



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 10 years ]
    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.

  2. 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.

  3. Two year survival [ Time Frame: 5 years ]
    To assess overall survival at 2 years



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Cristina Ferrone, MD 6176436189 cferrone@partners.org

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cristina Ferrone, MD    617-643-6189    cferrone@partners.org   
Principal Investigator: Cristina Ferrone, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Cristina Ferrone, MD Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Cristina R. Ferrone, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01952730    
Other Study ID Numbers: 12-436
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Keywords provided by Cristina R. Ferrone, MD, Massachusetts General Hospital:
Stage IV
Hepatic Lesions
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases