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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00588913
First received: December 20, 2007
Last updated: July 9, 2013
Last verified: August 2009
  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 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


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
Study Completion Date: August 2009
Primary Completion Date: March 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:

  • 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588913

Locations
Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Tokyo Women's Medical University
Tokyo, Japan, 162-8666
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

ClinicalTrials.gov Identifier: NCT00588913     History of Changes
Other Study ID Numbers: TRIC-CTR-GU-05-01, CDR0000581156
Study First Received: December 20, 2007
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

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:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Aldesleukin
Zoledronic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014