CURRENT PROTOCOLS

An Exploratory Analysis of Tumor Specific T Cells in Subjects with Clinically and Histologically Diagnosed Cancer

Spontaneous immune response to cancer is a well-documented phenomenon and many tumor antigens that are currently targets for therapy have been identified.  The natural anti-tumor response to these antigens generates T cells that can specifically target tumor cells expressing these antigens.  These T cells enter the circulation and are detectable from peripheral blood.  Therefore, one promising approach to the detection of cancer is to look for these tumor-specific T cells.  Since T cells are able to expand in response to small doses of antigen, it may be possible to detect cancer in very early stages.

The primary objective of this study is to analyze baseline results for frequency of tumor specific T cells in subjects with clinically and histologically diagnosed cancer.  Comparisons will be made between HLA-A2 positive and negative subjects with different types of cancer and different staging

Inclusion Criteria (conditions the patient must meet)

1. Male or female subjects ≥ 18 years of age and able to understand and give written informed consent.

2. Clinical and Histological diagnosis of Cancer.

   • Initial Cancer Population: Melanoma (Stage I, II, IIIA, and IV)
   • Subsequent Cancer Populations:  To be determined.

Exclusion Criteria (Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:)

1. Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.

2. Autoimmune disease:  subjects with a documented history of symptomatic autoimmune disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]) that has or may require systemic therapy.

3. Any underlying medical condition, which in the opinion of the Investigator will obscure the interpretation of adverse events.

4. Concomitant therapy with any anticancer agent; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids at time of enrollment.  Replacement doses of corticosteroids are allowed in subjects with adrenal insufficiency.

5. Prior biologic therapy of cancer.

Study Regimen

After the subject signs a written informed consent, the medical history and concomitant medications will be reviewed.  If the patient meets eligibility criteria, a blood sample will be obtained and submitted to Cosmo Bioscience, Inc. for immunologic analysis (Visit 1).  All subjects who are HLA-A2 positive will be contacted by phone call 6 months after the first visit to gather follow-up information (Visit 2).  Cosmo Bioscience will pre-determine subjects eligible to complete Visit 3.  Subjects who are eligible for Visit 3 will be seen at the Northern California Melanoma Center where follow-up information will be obtained and a blood sample obtained and sent to Cosmo Bioscience, Inc. for immunologic analysis.

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