Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176501
Status:
TERMINATED
Last Update Posted:
2014-01-06
First Post:
2005-09-12
Brief Title:
Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Immunotherapy for Patients With Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE When irradiated donor lymphocytes are infused into the patient they may help the patients 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
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 clinicalradiological 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
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 clinicalradiological 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CINJ 080410 | OTHER | CINJ | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |