CT-011 and p53 Genetic Vaccine for Advanced Solid Tumors
Status:
Withdrawn
Trial end date:
2011-10-31
Target enrollment:
Participant gender:
Summary
Background:
- The p53 gene normally helps to stop cancer cells from growing. However, when the p53
gene is mutated or damaged, cancer cells may grow unchecked. Researchers have been
working on a vaccine that will help the immune system recognize and destroy cells that
have the p53 mutation and may be cancerous.
- CT-011 is another drug that may help the body's immune system to fight cancer. This drug
blocks a chemical found on tumor cells that prevents the immune system from recognizing
and destroying them. Research studies have shown that CT-011 slows the growth of tumors.
By combining the p53 vaccine and CT-011, researchers hope to slow or stop tumor growth
in people whose cancer that has not responded to standard treatments.
Objectives:
- To test the safety and effectiveness of CT-011 and the p53 genetic vaccine to treat adults
with solid tumors that have not responded to standard treatments.
Eligibility:
- People at least 18 years of age who have solid tumors that have not responded to standard
treatments.
Design:
- Participants will be screened with a medical history and physical exam. They will also
have blood tests and tumor imaging studies.
- Participants will receive the p53 vaccine as an injection in the arm or thigh.
- Two days after receiving the p53 vaccine, those in the study will receive CT-011 as an
infusion over about 2 hours. Participants will be monitored during the infusion for any
side effects.
- The combination of p53 vaccine and CT-011 will be repeated every 3 weeks (one cycle).
Treatment will continue as long as the side effects are not severe and the tumor does
not grow.
- Three weeks after the second dose of p53 vaccine and CT-011, participants will have a
full physical exam. They will also have blood tests, and tumor imaging studies. This
exam set will be repeated after every two cycles of p53 vaccine and CT-011.
- Participants will have regular follow-up visits for up to a year after stopping
treatment.