Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01386502
Brief 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.
Detailed Description:
Background:
* PD1 is an inhibitory receptor that belongs to CD28-B7 family.
* PD1 binds to two ligands PD-L1 and PD-L2 to down modulate T-cell immune responses.
* PD1 is expressed on T cells, B cells, and NK cells.
* The over expression of PD-1 ligand (PD-L1) in tumors is associated with an immune suppression and poor prognosis.
Objectives:
* To determine the safety and tolerability of escalating doses of anti PD1 antibody (CT-011) in combination with subcutaneous p53 vaccine.
* To determine the immune response to wt p53 (264-272) peptide.
* To determine the clinical efficacy of this combination.
Eligibility:
* 18 years of age or older, not pregnant or nursing and not immunocompromised or having an autoimmune disease.
* HLA-A2 haplotype.
* ECOG performance status of 0-1.
* Advanced solid tumors over expressing p53 protein with a histological confirmation of the original primary tumor via the Pathology Laboratory, CCR , NCI.
Design:
* Single arm, pilot/phase I trial in patients receiving a fixed dose of vaccine in combination with an escalating dose of CT-011.
* The vaccine will be administered subcutaneously every 3 weeks followed by CT-011 two days after each vaccine until disease progression or toxicity.
* Patients will undergo blood draw or aphaeresis for immunologic assays prior to starting treatment and after every second cycle.
* Patients will be assessed for overall safety, immunologic efficacy, tumor response using RECIST criteria and survival.
* Patients will be followed for up to two years after the last vaccination for assessment of safety and efficacy.
Study:
NCT01386502
Study Brief:
Protocol Section:
NCT01386502