Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Immunotherapy for Patients With Renal Cell Carcinoma|
- Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Rate and Kinetics of Clinical/Radiological Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Rate of Graft-vs-host Disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Experimental: Irradiated allogeneic lymphocytes||
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).
- 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.
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|