CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51biological
Likely dose
NY-ESO-1b peptide plus CpG 7909 and Montanide ISA-51 (dose not specified in published record)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed metastatic, measurable cancer or resected high-risk Stage III/IV; resected Stage II, III, or IV non-small cell lung cancer or esophageal cancer who have declined, failed, or completed standard therapy
  • ✓Tumor expression of NY-ESO-1 or LAGE-1 antigen
  • ✓HLA-A2 positive
  • ✓Karnofsky performance status ≥60%
Key exclusion· 8
  • ✕Clinically significant heart disease
  • ✕Other serious illnesses or serious intercurrent illness requiring hospitalization
  • ✕Taking immunosuppressive drugs
  • ✕Autoimmune disease

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

Search/NCT00199836
NCT00199836Phase 1Completed
CompareCT.gov

A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.

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

In Brief

A Phase 1 clinical trial evaluating NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51 for Cancer and Neoplasm. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Neoplasm
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 3, 2003
Primary CompletionSep 5, 2005
Study CompletionJun 6, 2006
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 20.8 years ago

Interventions

NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51biological