Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Phase 2TerminatedNCT00176501

Rutgers, The State University of New Jersey3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Cancer

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Rate and Kinetics of Clinical/Radiological Response

Time frame: 5 years

Rate of Graft-vs-host Disease

Time frame: 5 years

Data from ClinicalTrials.gov

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