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
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: Primary for Cohort A: I. To assess the feasibility and safety of autologous transforming growth factor beta (TGFb) resistant (DNRII transduced) and NGFR transduced tumor infiltrating lymphocytes (TIL) in patients with metastatic melanoma. Primary for Cohort B: I. To assess the feasibility and safety of autologous TGBβ resistant (DNRII transduced) TIL in patients with metastatic melanoma. Feasibility will be defined as the production of virally transduced T cells and treatment of patients with these cells SECONDARY OBJECTIVES: Secondary for Cohort A: I. To determine the survival and immune function of TGFb resistant (DNRII transduced) TIL in vivo. II. To assess the anti-tumor effects of TGFb resistant (DNRII transduced) TIL. Secondary for Cohort B: I. To determine the survival and immune function of TGFβ resistant (DNRII transduced) TIL in vivo II. To assess the anti-tumor effects of TGFβ resistant (DNRII transduced) TIL. OUTLINE: Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses). After completion of study treatment, patients are followed up at 6 and 12 weeks, every 3 months for 1 year and then yearly for 10 years.
Age
12–70
Sex
ALL
Healthy volunteers
Not accepted
