Pilot Study of GVAX in Colorectal Cancer Cells

NCT01952730 | Terminated Phase 1 Results DMC

• 1 other identifier: 12-436
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Stage IV; Hepatic Lesions

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity

  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.

  2 years

Secondary Outcomes (3)

• Progression Free Survival

  75 months

• Immune Response

  2 years

• Two Year Survival

  2 years

Study Arms (1)

Experimental Treatment Arm

EXPERIMENTAL

GVAX, up to 6 vaccinations, administered via injection

Biological: GVAX

Interventions

GVAX BIOLOGICAL

Experimental Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Cristina R. Ferrone, MD
• Organization: Massachusetts General Hospital

CFERRONE@PARTNERS.ORG

617-643-6189

Study Officials

• Cristina Ferrone, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: September 30, 2013
• Study Start: November 8, 2013
• Primary Completion: September 1, 2018
• Study Completion: February 1, 2020
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Locations

US (1)