Study of “NY-ESO-1 ISCOMATRIX” in Patients With High-Risk, Resected Melanoma

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.

Official Title

Randomized, Double-Blind Phase II Trial of “NY-ESO-1 ISCOMATRIX” Vaccine and “ISCOMATRIX” Adjuvant Alone in Patients With Resected Stage IIc, III or IV Malignant Melanoma

Conditions

Melanoma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Rate of Relapse-free Survival at 18 months.

Secondary Outcome Measures:

• Safety
• NY-ESO-1 immunity
• Relapse-free Survival and Overall Survival

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.

Study Start

September 2005; Study completion: September 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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 pt 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:

• 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.

Total Enrolment

100

Contact Details

• Sydney Melanoma Unit – Royal Prince Alfred Hospital, Camperdown (Sydney), New South Wales, 2050, Australia
• Newcastle Melanoma Unit – Newcastle Mater Misericordiae Hospital, Newcastle, New South Wales, 2298, Australia
• Mater Medical Centre, Princess Alexandra Hospital, Woolloongabba (Brisbane), Queensland, 4102, Australia
• Austin Health (Ludwig Institute Oncology Unit), Heidelberg (Melbourne), Victoria, 3084, Australia
• Peter MacCallum Cancer Centre, East Melbourne, Victoria, 3002, Australia
• Sir Charles Gairdner Hospital, Nedlands (Perth), Western Australia, 6009, Australia