A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer.
Biological: NY-ESO-1b peptide plus CpG 7909 and Montanide ISA-51
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.|
- NY-ESO-1 specific humoral immunity
- NY-ESO-1 specific cellular immunity
- DTH to NY-ESO-1b peptide
- Toxicities and adverse events
- Tumor response
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||December 2005|
This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5mL of Montanide ISA-51 and 1mg of CpG7909 given every three weeks for four doses by subcutaneous injection. There will be a three-week follow-up period after the fourth injection making the cycle 13 weeks long. In the absence of toxicity and progressive disease, a second cycle will be offered to patients who have received four vaccinations.
The primary objective is to evaluate the immune response (antibodies, CD8+ T cells, and DTH) and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide in patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document tumor responses in patients with evaluable or measurable disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199836
|Principal Investigator:||Nasser K Altorki, MD||Weill Medical College of Cornell University|