NCT00176501

Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Immunotherapy for Patients With Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2004-08-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2005-09-15
• Last updated: 2014-01-06
• Results posted: 2014-01-06

Locations

1 site across 1 country: United States