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Study of NY-ESO-1 ISCOMATRIX® in Patients With Measurable Stage III or IV Melanoma
Basic Trial Information
Summary The purpose of this clinical trial cohort tests the effect of adding low dose cyclophosphamide to treatment with NY-ESO-1 ISCOM® vaccine, in patients with measurable advanced malignant melanoma (unresectable stage III or metastatic melanoma). Further Study Information 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. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Ludwig Institute for Cancer Research
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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