Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunotherapy for Patients With Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: therapeutic allogeneic lymphocytes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Kinetics of Clinical/Radiological Response |  | 5 years | 
| Rate of Graft-vs-host Disease |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer