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Sponsored by: |
Tokyo Women's Medical University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00588913 |
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.
Condition | Intervention | Phase |
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Kidney Cancer Metastatic Cancer |
Biological: aldesleukin Biological: therapeutic autologous lymphocytes Drug: zoledronic acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal carcinoma
Meets 1 or more of the following criteria:
Patients with clear cell renal carcinoma must have undergone nephrectomy prior to study entry
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Japan | |
Kyoto University Hospital | Recruiting |
Kyoto, Japan, 606-8507 | |
Contact: Nagahiro Minato, MD, PhD 81-75-753-4659 | |
Tokyo Women's Medical University | Recruiting |
Tokyo, Japan, 162-8666 | |
Contact: Hirohito Kobayashi 81-3-3353-8111 |
Study Chair: | Hirohito Kobayashi | Tokyo Women's Medical University |
Study ID Numbers: | CDR0000581156, TRIC-CTR-GU-05-01 |
Study First Received: | December 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00588913 History of Changes |
Health Authority: | Unspecified |
recurrent renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma lung metastases |
Urinary Tract Neoplasm Kidney Cancer Anti-HIV Agents Zoledronic acid Bone Density Conservation Agents Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Recurrence Carcinoma Diphosphonates |
Aldesleukin Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Clear Cell Renal Cell Carcinoma Neoplasm Metastasis Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Bone Density Conservation Agents Urologic Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Urologic Diseases Anti-Retroviral Agents Kidney Neoplasms Therapeutic Uses |
Neoplasm Metastasis Kidney Diseases Neoplasms by Histologic Type Zoledronic acid Anti-HIV Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Aldesleukin Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |