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Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: December 20, 2007   Last Updated: February 6, 2009   History of Changes
Sponsored by: Tokyo Women's Medical University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00588913
  Purpose

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
Kidney Cancer
Metastatic Cancer
Biological: aldesleukin
Biological: therapeutic autologous lymphocytes
Drug: zoledronic acid
Phase I
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Aldesleukin Zoledronic acid
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Secondary doubling time of tumor growth [ Designated as safety issue: No ]
  • Overall response [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 80-100%
  • 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
  • Corrected calcium level ≤ 10.0 mg/dL
  • C-reactive protein ≤ 0.4 mg/dL by standard quantification
  • Not pregnant nor nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection with hepatitis virus or HIV

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588913

Locations
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        
Sponsors and Collaborators
Tokyo Women's Medical University
Investigators
Study Chair: Hirohito Kobayashi Tokyo Women's Medical University
  More Information

Additional Information:
No publications provided

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009