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Study of NY-ESO-1 ISCOMATRIX® in Patients With Measurable Stage III or IV Melanoma

NCT00518206 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-10-25

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

NY-ESO-1 ISCOMATRIX® vaccine

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.

DRUG

Cyclophosphamide

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.

Sponsors & Collaborators

  • Austin Health

    collaborator OTHER_GOV

  • Peter MacCallum Cancer Institute

    collaborator UNKNOWN

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Jonathan S Cebon, FRACP, MBBS, PhD · Ludwig Institute for Cancer Research - Oncology Unit

  • Ian D Davis, FRACP, FAChPM, MBBS, PhD · Ludwig Institute for Cancer Research - Oncology Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-28
Primary Completion
2010-01-22
Completion
2010-01-22

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518206 on ClinicalTrials.gov