NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
To estimate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED in patients with tumor type known to express NY-ESO-1 or LAGE-1 using frequency, severity, and duration of treatment-related adverse effects as endpoints.
Non-Small Cell Lung Cancer
Biological: NY-ESO-1 plasmid DNA Cancer Vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Immunological Evaluation of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Given by Particle-Mediated Epidermal Delivery (PMED) in Patients With Tumor Type Known to Express NY-ESO-1 or LAGE-1 Antigen.|
- estimate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED in patients with tumor type known to express NY-ESO-1 or LAGE-1 using frequency, severity, and duration of treatment-related adverse effects as endpoints.
- evaluate NY-ESO-1 specific cellular and humoral immunity by determination of: a)NY-ESO-1 specific antibody, NY-ESO-1 specific CD8+ and CD4+ cells and b) delayed-type-hypersensitivity [DTH]) induced by NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
- document tumor response
|Study Start Date:||May 2004|
|Study Completion Date:||May 2007|
Eligible patients with tumor type known to express NY-ESO-1 or LAGE-1 antigen will be assigned to cohorts. NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine will be administered by PMED at a pressure of 500 psi using the XR-1 Powderject delivery device. The 4 microgram dosage of NY-ESO-1 will be administered as 4 X 1 microgram PMEDs in close proximity. Similarly, the 8 microgram dosage will be administered as 8 X 1 microgram PMEDs. The third cohort of patients will receive the 8 microgram dosage as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 microgram PMEDs per day.
Blood samples will be obtained at baseline, 2 weeks after each vaccination, prior to the second and third vaccination, and 4 weeks after the third vaccination for the assessment of clinical hematology, biochemistry measurements and immunology responses. Patients will be evaluated for toxicity throughout the study.
DTH testing will be performed with NY-ESO-1 protein in all patients, with NY-ESO-1b peptide in HLA-A2+ patients and with NY-ESO-1 DP4 peptide in HLA-DP4+ patients at baseline and at the 2-week visit following the first and third vaccinations.
NY-ESO-1 and/or LAGE-1 specific antibodies will be assessed in all patients by ELISA using recombinant NY-ESO-1 protein. NY-ESO-1 specific CD4+ and CD8+ T cells will be assessed in all patients by tetramer and/or ELISPOT assays.
Disease status will be assessed at baseline and 4 weeks after the third vaccination in patients with measurable disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199849
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10021|
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Padmanee Sharma, MD PhD||UT MD Anderson Cancer Center Genitourinary Med Onc|
|Principal Investigator:||Nasser K Altorki, MD||Weill Medical College of Cornell University|