Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: Primary * Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by autologous lymphocyte infusion, ESO-1 peptide vaccination comprising ESO-1:157-165 (165V) and Montanide ISA-51, and interleukin-2. Secondary * Determine the survival of the infused lymphocytes in patients treated with this regimen. * Determine the long-term immune status of patients treated with this regimen. OUTLINE: Patients are stratified according to type of lymphocyte infusion (ESO-1-reactive tumor-infiltrating lymphocytes \[TIL\] vs ESO-1 reactive peripheral blood lymphocytes \[PBL\]). * Autologous lymphocyte collection and expansion: Autologous PBL or TIL are collected from patients during leukapheresis or biopsy. The cells are sensitized in vitro with ESO-1:157-165 (165V) melanoma antigen and expanded. * Lymphocyte-depleting nonmyeloablative preparative chemotherapy: Patients receive lymphocyte-depleting nonmyeloablative preparative chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 15-30 minutes on days -5 to -1. * Autologous lymphocyte infusion: Autologous PBL or TIL are reinfused on day 0\*. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 1 and continuing until blood counts recover. * ESO-1 peptide vaccination: Patients receive ESO-1 peptide vaccination comprising ESO-1:157-165 (165V) peptide emulsified in Montanide ISA-51 SC on days 0\*-4, 11, 18, and 25. * Interleukin therapy: Patients receive interleukin-2 IV over 15 minutes 3 times daily on days 0\*-4. NOTE: \*Day 0 is 1-4 days after the last dose of fludarabine. Patients achieving stable disease or partial response may receive up to 1 retreatment course. Patients with progressive disease after infusion of PBL may receive retreatment with TIL, if available. Patients are followed at 4-5 weeks, every 3-4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 2-3 years.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
