NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00199849|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Bladder Cancer Non-Small Cell Lung Cancer Esophageal Cancer Sarcoma||Biological: NY-ESO-1 plasmid DNA Cancer Vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||May 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|