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Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irradiated allogeneic lymphocytes

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate and Kinetics of Clinical/Radiological Response
Rate of Graft-vs-host Disease

Full Information

First Posted
September 12, 2005
Last Updated
November 18, 2013
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00176501
Brief Title
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Official Title
Immunotherapy for Patients With Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irradiated allogeneic lymphocytes
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Description
If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Primary Outcome Measure Information:
Title
Response Rate
Description
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 Outcome Measure Information:
Title
Rate and Kinetics of Clinical/Radiological Response
Time Frame
5 years
Title
Rate of Graft-vs-host Disease
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

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