Back to resultsAdoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
Primary Purpose
Kidney Cancer, Metastatic Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
aldesleukin
therapeutic autologous lymphocytes
zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, lung metastases
Eligibility 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
Sites / Locations
- Kyoto University Hospital
- Tokyo Women's Medical University
Outcomes
Primary Outcome Measures
Frequency and severity of adverse events based on NCI-CTCAE version 3.0
Proportion of gd T-cells in peripheral blood
Secondary Outcome Measures
Secondary doubling time of tumor growth
Overall response
Full Information
NCT ID
NCT00588913
First Posted
December 20, 2007
Last Updated
July 9, 2013
Sponsor
Tokyo Women's Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00588913
Brief Title
Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo Women's Medical University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Metastatic Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, lung metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Frequency and severity of adverse events based on NCI-CTCAE version 3.0
Title
Proportion of gd T-cells in peripheral blood
Secondary Outcome Measure Information:
Title
Secondary doubling time of tumor growth
Title
Overall response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirohito Kobayashi
Organizational Affiliation
Tokyo Women's Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
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