Metastatic Cancer Clinical Trial
Official title:
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
RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are
treated in the laboratory to stimulate the immune system in different ways and stop tumor
cells from growing. Aldesleukin may help the laboratory-treated white blood cells stay in
the body longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic
acid may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive
immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in
treating patients with stage IV kidney cancer and lung metastases.
OBJECTIVES:
- 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
adverse events.
- Determine the duration of in vivo persistence of the transferred gd T cells in
patients.
- 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
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