- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176501
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Immunotherapy for Patients With Renal Cell Carcinoma
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Irradiated allogeneic lymphocytes
|
If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate and Kinetics of Clinical/Radiological Response
Time Frame: 5 years
|
5 years
|
Rate of Graft-vs-host Disease
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000540187
- P30CA072720 (U.S. NIH Grant/Contract)
- CINJ #080410 (Other Identifier: CINJ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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