Expired Study
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New Brunswick, New Jersey 08903


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00176501


Primary Contact:

Principal Investigator
Roger Strair, MD, PhD
Cancer Institute of New Jersey


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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