Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
NCT ID: NCT00199901
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2005-09-30
2011-12-31
Brief Summary
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Detailed Description
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Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).
Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vaccine
NY-ESO-1 ISCOMATRIX® vaccine
NY-ESO-1 ISCOMATRIX®
100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.
Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
Adjuvant Alone
ISCOMATRIX® adjuvant alone
ISCOMATRIX® adjuvant
120 μg of ISCOMATRIX® adjuvant
Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
Interventions
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NY-ESO-1 ISCOMATRIX®
100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.
Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
ISCOMATRIX® adjuvant
120 μg of ISCOMATRIX® adjuvant
Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
Eligibility Criteria
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Inclusion Criteria
* Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
* Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
* Within six months of surgery for melanoma.
* Full recovery from surgery.
* No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.)
* Age 18 years or older.
* Able to give written informed consent.
* Vital laboratory parameters within normal range, or protocol specified ranges.
Exclusion Criteria
* Resected cerebral metastases.
* Ocular melanoma.
* Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ.
* Using immunosuppressive drugs.
* Anticoagulation.
* Known HIV positivity.
* Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
* Not available for immunological and clinical follow-up assessments.
* Participation in prior clinical trial involving an investigational agent within last 4 weeks.
* Previous isolated limb perfusion (ILP).
* Pregnancy or breastfeeding.
* Refusal or inability to use effective means of contraception for women of childbearing potential.
* Mental impairment that may compromise ability to give informed consent and to comply with study requirements.
18 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Ludwig Institute for Cancer Research
OTHER
Responsible Party
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Principal Investigators
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Prof. Jonathan S Cebon, MBBS PhD
Role: STUDY_CHAIR
Ludwig Institute for Cancer Research
Prof. Martin Gore, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden Hospital
Locations
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Sydney Melanoma Unit - Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia
Mater Medical Centre, Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin Health (Ludwig Institute Oncology Unit)
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
University of Auckland (Waitemata DHB)
Auckland, , New Zealand
University Hospital - Birmingham
Birmingham, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
St Georges Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Mount Vernon Hospital
Northwood, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Southampton University Hospitals
Southampton, , United Kingdom
Countries
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Other Identifiers
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LUD2003-009
Identifier Type: -
Identifier Source: org_study_id
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