Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00176501
Last Updated: 2014-01-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2004-08-31
2008-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Irradiated allogeneic lymphocytes
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Roger Strair, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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CINJ #080410
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000540187
Identifier Type: -
Identifier Source: org_study_id
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