Phase I/II Study of Adoptive Immunotherapy Comprising Pyrophosphomonoester Antigen-stimulated T Cells, IL-2, and Nitrogen-containing Bisphosphonates in Patients With Stage IV Renal Cell Carcinoma
- Determine the safety of adoptive immunotherapy comprising
2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta (gd) T cells, zoledronate,
and IL-2 after nephrectomy, especially with regard to the incidence and frequency of
- Determine the duration of in vivo persistence of the transferred gd T cells in
- Determine the doubling time of tumor growth before and after adoptive immunotherapy.
- Determine the tumor-size reducing effect of adoptive immunotherapy based on the Best
Overall Response Chart.
OUTLINE: Patients undergo leukapheresis for the harvest of peripheral blood mononuclear
cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin
for 11 days. Patients then receive the expanded Gamma Delta T cells, aldesleukin, and
zoledronic acid once a month for 6 months.
After completion of study treatment, patients are followed for up to 1 month.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Frequency and severity of adverse events based on NCI-CTCAE version 3.0
Tokyo Women's Medical University
United States: Federal Government