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
This clinical trial cohort tests the combination of NY-ESO-1 ISCOMATRIX® vaccine given after
low dose cyclophosphamide in patients with advanced melanoma.
NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX®
adjuvant enhances immune responses. Low dose cyclophosphamide has been shown to suppress a
population of lymphocytes called "regulatory T cells". Regulatory T cells can interfere
with immune responses in patients with cancer. The rationale for treating this new cohort
of patients in the study is to use a small dose of cyclophosphamide to suppress the
regulatory T cells and thus try to increase patient responses to the NY-ESO-1 ISCOMATRIX®
Eligible patients will receive three intramuscular injections of NY-ESO-1 ISCOM® vaccine at
approximately four-week intervals (week 1, week 5, week 9). Low dose cyclophosphamide will
be administered by intravenous infusion one day prior to the each NY-ESO-1 ISCOM® vaccine.
Tumor evaluations (CT scans and physical evaluations), safety evaluation (blood tests and
medical reviews) and immunological testing (special DTH skin tests and blood immunology
tests) will be performed before, during and at the end of the 11 week treatment cycle.
Treatment may continue for further cycles unless there is a reason to remove the patient
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of adding cyclophosphamide in the additional cohort on "Tumor Response": Measured as objective tumor response (RECIST criteria). Measured at 11 weeks but a superior response observed at a later timepoint will be recorded as the best response.
11 weeks or more
Prof. Jonathan S Cebon, FRACP, MBBS, PhD
Ludwig Institute for Cancer Research
Australia: Department of Health and Ageing Therapeutic Goods Administration