Vaccination of Patients With Stage IV Melanoma With Dendritic Cells
Melanoma, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Dendritic, Vaccine, Melanoma, Stage IV metastatic melanoma
Eligibility Criteria
Inclusion Criteria: Stage M1a, M1b, M1c biopsy proven metastatic melanoma Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2). Karnofsky performance status greater than/equal to 80%. Measurable metastatic lesions by physical exam or scans. Acceptable CBC and blood chemistry results Adequate renal function. Written informed consent. Exclusion Criteria: Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma. Patients who have received chemotherapy less than 4 weeks before beginning the trial. Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial. Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial. Patients with a history of central nervous system (CNS) metastatic melanoma. More than 5 hepatic lesions or any hepatic lesion larger than 5 cm. Baseline serum LDH greater than 4 times the upper limit of normal. Patients who are HIV positive. Patients who are pregnant. Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial. Patients with asthma, angina pectoris or congestive heart failure. Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis. Patients with active infections including viral hepatitis. Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
Sites / Locations
- Mary Crowley Medical Research Center: Baylor University Medical Center