Phase II Study in Metastatic Melanoma Using Lymphocytes Reactive With the gp100 Antigen and Immunization Using a Recombinant rF-gp100P209 Virus Encoding a gp100 Peptide Following a Nonmyeloablative Lymphocyte Depleting Regimen
Abstract
This study will examine the effectiveness of treating advanced melanoma with special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The cells are given along with infusions of a growth factor-like substance called interleukin-2 (IL-2) and an experimental vaccine called fowlpox gp100. This vaccine consists of a peptide (part of a protein) called gp100 that is often found in melanoma tumors and chicken virus (fowlpox) that has been altered so that it cannot produce illness in humans.
Patients 16 years of age and older with melanoma that has spread beyond the original site and that does not respond to standard treatment may be eligible for this study. Candidates are screened with a medical history and physical examination, chest x-ray, electrocardiogram, blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor. Because the experimental preparation is based on tissue type, only patients with tissue type HLA-A\*0201 may participate. Tissue type is determined by a blood test.
Participants undergo the following procedures:
* Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this procedure, special cells with good tumor-fighting ability are selected and removed for later re-infusion into the patient. To collect the cells, blood is withdrawn through a needle in an arm vein and directed through a catheter into a cell-separating machine. The lymphocytes are removed and the rest…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 58 participants or records.
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