CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
NY-ESO-1 Plasmid DNA Cancer Vaccinebiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically proven tumor type known to express NY-ESO-1 or LAGE-1 (prostate, breast, bladder, hepatocellular, synovial sarcoma, leiomyosarcoma, head and neck, lung, esophageal, ovarian, neuroblastoma) or confirmed by RT-PCR, immunohistochemistry, or LAGE-1 expression by RT-PCR
  • ✓Advanced disease with decline, delay, failure, or completion of standard therapy
  • ✓Full recovery from prior surgery
  • ✓Expected survival of at least 6 months
Key exclusion· 9
  • ✕Clinically significant heart disease (NYHA Class III or IV)
  • ✕Serious infections requiring antibiotics or bleeding disorders
  • ✕Clinically significant liver or renal insufficiency requiring treatment
  • ✕Known HIV, Hepatitis B, or Hepatitis C positivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00199849
NCT00199849Phase 1Completed
CompareCT.gov

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.

Ludwig Institute for Cancer Research·interventional·Posted Sep 20, 2005·Updated Oct 10, 2022

In Brief

A Phase 1 clinical trial evaluating NY-ESO-1 Plasmid DNA Cancer Vaccine for Prostate Cancer and 4 related conditions. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Bladder Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Sarcoma
CountriesUnited States
CollaboratorsNew York Presbyterian Hospital, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 27, 2004
Primary CompletionSep 11, 2006
Study CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 20.8 years ago

Interventions

NY-ESO-1 Plasmid DNA Cancer Vaccinebiological

NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.