(-) CT-011 and p53 genetic vaccine for advanced solid tumors (clinicaltrials.gov) - Jan 1, 2012 - P1, N=0; N=27 -> 0; Completed -> Withdrawn
Enrollment • Trial withdrawn • Oncology • Pancreatic Cancer
|
|
This study has been withdrawn prior to enrollment.
First Received on June 30, 2011. Last Updated on December 30, 2011 History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01386502
Purpose
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.
Condition
Breast Cancer
Colon Cancer
Pancreatic Cancer
Sarcoma
Ovarian Cancer
Intervention
Biological: p53: 264-272 peptide
Drug: CT-011
Phase
Phase I
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer Pancreatic Cancer Soft Tissue Sarcoma
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
To determine the safety and tolerability of escalating doses of anti PD1 antibody (CT-011) in combination with subcutaneous p53 vaccine.
Secondary Outcome Measures:
To determine the immune response to wt p53 (264-272) peptide.
To determine the clinical efficacy of this combination.
Enrollment: 0
Study Start Date: June 2011
Study Completion Date: October 2011
|