CT-011 and p53 Genetic Vaccine for Advanced Solid Tumors

Withdrawn before enrolling · Phase 1

Conditions studied: Breast Cancer, Colon Cancer, Pancreatic Cancer, Sarcoma, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT01386502

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2011-06-15

Expected to finish

2011-10-31

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Concurrent therapy with any other investigational agent(s).
• Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. Patients with treated brain metastases which have been stable for 6 months or longer will be eligible.
• Patients who are immunocompromised (HIV positive) or with active Hepatitis B or C; HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with CT-011 or p53. .
• Patients who have underlying immune deficiency or history of autoimmune disease (including but not limited to SLE, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, regional enteritis or other diseases known or presumed to be of autoimmune origin.)
• Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH).
• Concurrent use of systemic steroids except physiologic doses for systemic steroid replacement or local therapy. Physiologic doses are defined as daily systemic therapy used to replace endogenous steroids because of HPA axis dysfunction or other physiological abnormality.
• History of a second active malignancy in the last 2 years other than non-melanoma skin cancers or carcinoma in situ of the cervix.
• Patients with active infections requiring antibiotics.
• Patients with New York Heart Association stage 2 or greater heart failure, unstable angina or cardiac arrhythmias requiring therapy including atrial fibrillation.
• Pregnant women or nursing mothers are ineligible since the effect of this investigational treatment on the health of the fetus is not known.
• If, in the opinion of the Principal or Associate Investigators, it is not in the best medical interest of the patient to enter this study, the patient will not be eligible.
• Patients with history of chronic radiation injury/inflammation due to the risk of perforation in the event of autoimmune inflammation, or history of chronic diarrhea due to previous treatments or surgery.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.