Immunotherapy for Patients With Renal Cell Carcinoma
18 Years
75 Years
Both
Kidney Cancer
Trial Information
Immunotherapy for Patients With Renal Cell Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Roger Strair, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000540187
NCT ID:
NCT00176501
Start Date:
August 2004
Completion Date:
August 2008
Related Keywords:
- Kidney Cancer
- recurrent renal cell cancer
- clear cell renal cell carcinoma
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
