Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Phase 2

Terminated

• Conditions: Kidney Cancer
• Interventions: Biological: therapeutic allogeneic lymphocytes

• Registration Number: NCT00176501
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2013-11
• Results First Submitted: 2013-11-18
• Results First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Results First Posted: 2014-01-06
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irradiated allogeneic lymphocytes	therapeutic allogeneic lymphocytes	-

Primary Outcome Measures

Name	Time	Method
Response Rate	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Rate and Kinetics of Clinical/Radiological Response	5 years
Rate of Graft-vs-host Disease	5 years

Trial Locations

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States