Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588913
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Metastatic Cancer Biological: aldesleukin Biological: therapeutic autologous lymphocytes Drug: zoledronic acid Phase 1 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Primary Outcome Measures :
  1. Frequency and severity of adverse events based on NCI-CTCAE version 3.0
  2. Proportion of gd T-cells in peripheral blood

Secondary Outcome Measures :
  1. Secondary doubling time of tumor growth
  2. Overall response

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal carcinoma

    • Stage IV disease with lung metastases
  • Bidimensionally measurable lung metastases by CT scan
  • Meets 1 or more of the following criteria:

    • No change in disease status or progressive disease after prior aldesleukin administration for 3 months or more
    • Lung metastases after treatment with prior nephrectomy
  • Patients with clear cell renal carcinoma must have undergone nephrectomy prior to study entry

    • Patients with progression of metastatic lung cancer after nephrectomy also must have received interferon alfa for 3 months or more (prior to study entry)


  • ECOG performance status 0-1
  • Life expectancy > 6 months
  • Leukocyte count ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin ≤ 1.5 mg/dL
  • AST/ALT ≤ 2.5 times normal
  • Serum creatinine ≤ 1.7 mg/dL
  • LDH ≤ 1.5 times normal
  • Not pregnant nor nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection with hepatitis virus or HIV
  • No poorly controlled heart failure or arrhythmia
  • No hypercalcemia that require medication
  • No C-reactive protein with an infectious disease that requires medication


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy, radiation therapy, or biologic therapy
  • No prior bone marrow transplantation or organ transplantation
  • No concurrent steroid therapy
  • No concurrent antidepressant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588913

Kyoto University Hospital
Kyoto, Japan, 606-8507
Tokyo Women's Medical University
Tokyo, Japan, 162-8666
Sponsors and Collaborators
Tokyo Women's Medical University
Study Chair: Hirohito Kobayashi Tokyo Women's Medical University Identifier: NCT00588913     History of Changes
Other Study ID Numbers: TRIC-CTR-GU-05-01
CDR0000581156 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: August 2009

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
lung metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents