Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer
Verified September 2014 by Duke University
Information provided by (Responsible Party):
Michael Morse, MD, Duke University
First received: June 26, 2013
Last updated: September 4, 2014
Last verified: September 2014
This is a pilot study to evaluate the safety of a vaccine that consists of an alphavirus replicon (VRP) encoding the protein (CEA) that has been found to be associated with cancers such as colon cancer in patients that have stage III colon cancer. We will also evaluate the patient immune response to the vaccine.
Stage III Colon Cancer
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of Active Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer
Primary Outcome Measures:
- Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2015 (Final data collection date for primary outcome measure)
AVX701 Vaccine:4 x 10EE8 IU intramuscularly every 3 weeks for 4 total immunizations
Other Name: VRP-CEA(6D)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with active cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. There must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment.
- Evidence of metastatic disease.
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
- Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled superficial bladder cancer.
- Presence of an active acute or chronic infection including: a urinary tract infection , HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
- Patients with allergies to any component of the vaccine will be excluded from the protocol.
- Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
- Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890213
|Duke University Medical Center
|Durham, North Carolina, United States, 27710 |
||Michael Morse, MD
No publications provided
||Michael Morse, MD, Associate Professor, Duke University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 26, 2013
||September 4, 2014
||United States: Food and Drug Administration
United States: Duke University IRB
United States: NIH Office of Biotechnology Activities
Keywords provided by Duke University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases