CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
NY-ESO-1 ISCOMATRIX® vaccine +1 morebiological
Likely dose
NY-ESO-1 ISCOMATRIX® vaccine 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00518206
NCT00518206Phase 2Completed
CompareCT.gov

A Phase II Study of the Clinical and Immunological Effects of NY-ESO-1 ISCOM® Vaccine in Patients With Measurable Stage III and IV Malignant Melanoma

Ludwig Institute for Cancer Research·interventional·Posted Aug 20, 2007·Updated Oct 25, 2022

In Brief

A Phase 2 clinical trial evaluating NY-ESO-1 ISCOMATRIX® vaccine and Cyclophosphamide for Melanoma. Completed, enrolled 46 participants across 2 sites.

Detailed Summary

This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered as an intramuscular injection given every 4 weeks to subjects with measurable advanced malignant melanoma. Study objectives included determination of the anticancer activity, cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM vaccine administered alone or preceded by a single administration of low-dose cyclophosphamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia
CollaboratorsAustin Health, Peter MacCallum Cancer Institute

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 20, 2007
Enrollment StartNov 28, 2003
Primary CompletionJan 22, 2010
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.9 years ago

Interventions

NY-ESO-1 ISCOMATRIX® vaccinebiological

NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.

Cyclophosphamidedrug

Cyclophosphamide (300 mg/m\^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.