Status:
COMPLETED
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Institute of Cancer Research, United Kingdom
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.
Detailed Description
NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvan...
Eligibility Criteria
Inclusion
- Histologically proven malignant melanoma.
- 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
- Other serious or significant illnesses.
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00199901
Start Date
September 1 2005
End Date
December 1 2011
Last Update
October 12 2022
Active Locations (15)
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1
Sydney Melanoma Unit - Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
3
Mater Medical Centre, Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
4
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002