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Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176501
Recruitment Status : Terminated (Slow accrual)
First Posted : September 15, 2005
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: therapeutic allogeneic lymphocytes Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy for Patients With Renal Cell Carcinoma
Study Start Date : August 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: Irradiated allogeneic lymphocytes Biological: therapeutic allogeneic lymphocytes
If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 5 years ]
    With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.

Secondary Outcome Measures :
  1. Rate and Kinetics of Clinical/Radiological Response [ Time Frame: 5 years ]
  2. Rate of Graft-vs-host Disease [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176501

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United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
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Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
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Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT00176501    
Other Study ID Numbers: CDR0000540187
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ #080410 ( Other Identifier: CINJ )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014
Last Verified: November 2013
Keywords provided by Rutgers, The State University of New Jersey:
recurrent renal cell cancer
clear cell renal cell carcinoma
stage IV renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type