Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01386502
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2011-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CT-011 and p53 Genetic Vaccine for Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Trial of Escalating Doses of Anti-PD1 Monoclonal Antibody (CT-011) in Combination With p53 Vaccine in Adults With Advanced Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2011-10-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11-C-0198 | None | None | View |