Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
- Assess the safety and toxicity of cellular adoptive immunotherapy with autologous
tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and
post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
- Assess the duration of in vivo persistence of adoptively transferred lymphocytes.
- Evaluate the antitumor effect of adoptively transferred autologous TIL following
cyclophosphamide conditioning and post-infusion IL-2 in these patients.
OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous
tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion,
patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14
doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses).
Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without
cyclophosphamide), if indicated.
After completion of study treatment, patients are followed up periodically.
Cassian Yee, MD
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration