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| Descriptive Information Fields | |||||
| Brief Title † | Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer | ||||
| Official Title † | Immunotherapy for Patients With Renal Cell Carcinoma | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Response rate [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Rate and kinetics of clinical/radiological response [ Designated as safety issue: No ] Toxicity [ Designated as safety issue: Yes ] Rate of graft-vs-host disease [ Designated as safety issue: No ] |
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| Condition † | Kidney Cancer | ||||
| Intervention † | Drug: therapeutic allogeneic lymphocytes Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 60 | ||||
| Start Date † | March 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00176501 | ||||
| Organization ID | CDR0000540187 | ||||
| Secondary IDs †† | CINJ-4846 | ||||
| Study Sponsor † | Cancer Institute of New Jersey | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | October 22, 2008 | ||||