Clinical Trial Name - Fludarabine, Cyclophosphamide, and Vaccine Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified peripheral blood lymphocytes may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with vaccine therapy and aldesleukin may be an effective treatment for metastatic melanoma. PURPOSE: This phase II trial is studying how well giving fludarabine together with cyclophosphamide followed by vaccine therapy works in treating patients with metastatic melanoma.

OBJECTIVES: Primary - Determine if the administration of autologous anti-gp100:154-162 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes or tumor infiltrating lymphocytes and aldesleukin to patients following a nonmyeloablative but lymphoid-depleting preparative regimen will result in clinical tumor regression in patients with metastatic melanoma. Secondary - Determine the in vivo survival of TCR gene-engineered cells. - Determine the toxicity profile of this treatment regimen. - Determine whether treated patients develop anti-mouse TCR antibody. OUTLINE: - Leukapheresis and cell preparation: If tumor infiltrating lymphocytes (TIL) are not available, patients undergo leukapheresis to obtain peripheral blood mononuclear (PBL) cells which are subsequently cultured in the presence of anti-CD3 (OKT3) and aldesleukin. The TIL or PBL cells are then transduced by exposure to anti-gp100:154 T-cell receptor (TCR) genes and expanded in culture. - Preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine phosphate IV over 30 minutes on days -5 to - 1. - Cell infusion: Patients receive autologous anti-gp100:154-162 TCR gene-engineered peripheral blood lymphocytes or TIL IV over 20-30 minutes on day 0. Patients also receive aldesleukin IV over 15 minutes 3 times daily beginning on day 0 and continuing for up to 5 days. Patients may receive 1 retreatment course at 6-8 weeks after the last aldesleukin dose. Blood is collected periodically to determine in vivo survival of TCR gene-engineered cells via PCR and immunological laboratory methods. After completion of study treatment, Patients are followed periodically for 15 years.