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Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Study NCT00176501   Information provided by National Cancer Institute (NCI)
First Received: September 12, 2005   Last Updated: February 6, 2009   History of Changes

September 12, 2005
February 6, 2009
March 2005
October 2008   (final data collection date for primary outcome measure)
Response rate [ Designated as safety issue: No ]
This clinical trial will be a comparative study of 2 regimens for patients with metastatic renal cell carcinoma.
Complete list of historical versions of study NCT00176501 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Determination of rates and kinetics of clinical/radiographic response in each of the treatment arms;
  • Determination of toxicities associated with each of the treatment arms.
  • Determination of rates of graft versus host disease in each of the treatment arms;
 
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Immunotherapy for Patients With Renal Cell Carcinoma

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.

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.

Phase II
Interventional
Treatment, Open Label
Kidney Cancer
  • Biological: therapeutic allogeneic lymphocytes
  • Other: immunoenzyme technique
  • Other: laboratory biomarker analysis
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176501
 
CDR0000540187, CINJ-4846
Cancer Institute of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Roger Strair, MD, PhD Cancer Institute of New Jersey
National Cancer Institute (NCI)
October 2008

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