Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Trial Parameters
Brief Summary
Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.
Eligibility Criteria
Inclusion Criteria: * Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically. * Patients must be 18 years of age or older. * Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines. * Patients must have a performance status (PS) of 0 or 1 ECOG PS scale. * Patients must have the ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time. * Patients melanoma must be positive for both tyrosinase and HLA-A2 pathologic review from FNA, core or excisional biopsy of lesion. * Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram. * Patients that have undergone treatment with anti-CTLA-4, Cytotoxic T-Lymphocyte Antigen 4, antibody must have at least 6 weeks from last dose of CTLA-4 anti