Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
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.
Biological: therapeutic autologous lymphocytes
Drug: zoledronic acid
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
- Frequency and severity of adverse events based on NCI-CTCAE version 3.0 [ Designated as safety issue: Yes ]
- Proportion of gd T-cells in peripheral blood [ Designated as safety issue: No ]
- Secondary doubling time of tumor growth [ Designated as safety issue: No ]
- Overall response [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588913
|Kyoto University Hospital|
|Kyoto, Japan, 606-8507|
|Tokyo Women's Medical University|
|Tokyo, Japan, 162-8666|
|Study Chair:||Hirohito Kobayashi||Tokyo Women's Medical University|