Status:
TERMINATED
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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/...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00176501
Start Date
August 1 2004
End Date
August 1 2008
Last Update
January 6 2014
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903