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
18 Years
N/A
Both
Melanoma
Trial Information
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®
vaccine.
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
from study.
Inclusion Criteria:
- Stage IV (metastatic) or unresectable stage III malignant melanoma.
- Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
- Measurable disease (RECIST criteria).
- No other effective therapy available or appropriate.
- Expected survival of at least 4 months.
- Performance status (Karnofsky) 70% or greater.
- Vital laboratory parameters within normal range, or protocol specified ranges.
- Age 18 years or older.
- Able to give written informed consent.
Exclusion Criteria:
- Other serious or significant illnesses.
- Other malignancy within last 3 years, except for treated melanoma or non-melanoma
skin cancer and cervical cancer in situ.
- Known immunodeficiency
- Known HIV positivity
- Using systemic immunosuppressive drugs. (Exceptions: Specific COX-2 inhibitors; low
dose aspirin for acute cardiovascular event prevention; topical/inhaled steroids)
- Chemotherapy, immunotherapy or radiotherapy within last four weeks.
- Participation in prior clinical trial involving an investigational agent within last
4 weeks.
- Not available for immunological and clinical follow-up assessments.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
11 weeks or more
Safety Issue:
No
Principal Investigator
Prof. Jonathan S Cebon, FRACP, MBBS, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ludwig Institute for Cancer Research
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
LUD2002-013
NCT ID:
NCT00518206
Start Date:
December 2003
Completion Date:
November 2012
Related Keywords:
- Melanoma
- Clinical Trial
- Phase II
- Cancer Vaccine
- NY-ESO-1 protein, human
- ISCOMATRIX, immunological adjuvant
- Cyclophosphamide
- T-Cells, Regulatory
- Melanoma
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