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)

December 20, 2007
January 9, 2008
July 10, 2013
January 2006
March 2009   (Final data collection date for primary outcome measure)
  • Frequency and severity of adverse events based on NCI-CTCAE version 3.0
  • Proportion of gd T-cells in peripheral blood
Same as current
Complete list of historical versions of study NCT00588913 on Archive Site
  • Secondary doubling time of tumor growth
  • Overall response
Same as current
Not Provided
Not Provided
Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
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.


  • 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.

Phase 1
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Cancer
  • Metastatic Cancer
  • Biological: aldesleukin
  • Biological: therapeutic autologous lymphocytes
  • Drug: zoledronic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2009
March 2009   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000581156 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Not Provided
Not Provided
Not Provided
Tokyo Women's Medical University
Not Provided
Study Chair: Hirohito Kobayashi Tokyo Women's Medical University
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP