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Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Study NCT00176501.   Last updated on October 22, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title † Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Official Title † Immunotherapy for Patients With Renal Cell Carcinoma
Brief Summary

RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
Detailed Description

OBJECTIVES:

  • Determine the response rate in patients with metastatic renal cell carcinoma treated with HLA-partially matched related donor lymphocytes.
  • Determine the rate and kinetics of clinical/radiological response in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the rates of graft-vs-host disease in patients treated with this regimen.

OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically for research studies, including immunophenotypic analysis of cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target cells.

After completion of study treatment, patients are followed for 60 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Open Label
Primary Outcome Measure † Response rate [ Designated as safety issue: No ]
Secondary Outcome Measure † Rate and kinetics of clinical/radiological response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Rate of graft-vs-host disease [ Designated as safety issue: No ]
Condition † Kidney Cancer
Intervention † Drug: therapeutic allogeneic lymphocytes
Procedure: immunoenzyme technique
Procedure: laboratory biomarker analysis
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Completed
Enrollment † 60
Start Date † March 2005
Completion Date
Eligibility Criteria †

DISEASE CHARACTERISTICS:

  • Diagnosis of clear cell renal cell carcinoma

    • Metastatic disease
  • Measurable disease
  • Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy
  • No brain metastases by MRI or CT scan

  • HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available

    • Patients who have no partially matched immediate family member available are eligible if they have a fully HLA-matched donor

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Bilirubin ≤ 2 times upper limit of normal
  • Creatinine clearance ≥ 40 mL/min
  • AST ≤ 3 times ULN
  • Cardiac ejection fraction ≥ 45%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00176501
Organization ID CDR0000540187
Secondary IDs †† CINJ-4846
Study Sponsor † Cancer Institute of New Jersey
Collaborators †† National Cancer Institute (NCI)
Investigators †
Principal Investigator:     Roger Strair, MD, PhD     Cancer Institute of New Jersey    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2008
First Received Date † September 12, 2005
Last Updated Date October 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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