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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Padmanee Sharma, MD PhD
UT MD Anderson Cancer Center Genitourinary Med Onc
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|New York Presbyterian Hospital||New York, New York 10021|