Kidney Cancer
Conditions
Keywords
recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer
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.
Interventions
BIOLOGICALtherapeutic allogeneic lymphocytes
If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Rate and Kinetics of Clinical/Radiological Response | 5 years |
| Rate of Graft-vs-host Disease | 5 years |
Countries
United States
Participant flow
Recruitment details
Three subjects were enrolled from March 2005 through February 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.
Participants by arm
| Arm | Count |
|---|---|
| Irradiated Allogeneic Lymphocytes 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). | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Irradiated Allogeneic Lymphocytes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 55.3 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
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.
Time frame: 5 years
Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.
Secondary
Rate and Kinetics of Clinical/Radiological Response
Time frame: 5 years
Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.
Secondary
Rate of Graft-vs-host Disease
Time frame: 5 years
Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.