Viewing Study NCT00199849



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Study NCT ID: NCT00199849
Status: COMPLETED
Last Update Posted: 2022-10-10
First Post: 2005-09-12

Brief Title: NY-ESO-1 Plasmid DNA pPJV7611 Cancer Vaccine
Sponsor: Ludwig Institute for Cancer Research
Organization: Ludwig Institute for Cancer Research

Study Overview

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
Status: COMPLETED
Status Verified Date: 2022-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To evaluate the safety of NY-ESO-1 Plasmid DNA pPJV7611 Cancer Vaccine given by particle-mediated epidermal delivery PMED in patients with tumor types known to express NY-ESO-1 or LAGE-1
Detailed Description: NY-ESO-1 Plasmid DNA pPJV7611 Cancer Vaccine was administered by particle-mediated epidermal delivery PMED at a pressure of 500 psi using the XR-1 Powderject delivery device The 4 microgram dosage of NY-ESO-1 was administered as 4 X 1 microgram PMEDs in close proximity Similarly the 8 microgram dosage was administered as 8 X 1 microgram PMEDs The third cohort of patients received 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 were to 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 were to be evaluated for toxicity throughout the study

Delayed-type hypersensitivity DTH testing was to be performed at baseline and at the 2-week visit following the first and third vaccinations

NY-ESO-1 andor LAGE-1 specific antibodies were to be assessed in all patients by an enzyme-linked immunosorbent assay ELISA NY-ESO-1 specific CD4 and CD8 T-cells were to be assessed in all patients by tetramer andor ELISPOT assays

Disease status was to be assessed at baseline and 4 weeks after the third vaccination in patients with measurable disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
LUD2002-006 OTHER Ludwig Institute for Cancer Research None