Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002589
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Lymphocyte Therapy in Treating Patients With Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Adjuvant Autolymphocyte Therapy ALT For Patients With Non-Metastatic Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Treating a persons lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body
PURPOSE This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer
PURPOSE This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer
Detailed Description:
OBJECTIVES
Evaluate the ability of autologous lymphocyte therapy ALT given as adjuvant therapy following nephrectomy andor complete surgical resection of any metastatic disease to delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma
Determine the incidence of tumor recurrence and the survival of these patients treated with this regimen
Determine the toxicitymorbidity of this regimen in these patients
Explore the relationship between clinical response and in vitro autologous lymphocyte characteristics including lytic activity cytokine production response to cytokines and phenotypic profile in these patients treated with this regimen
Assess patient immune status before during and after therapy
OUTLINE Patients are stratified according to postnephrectomy interval less than 3 months vs more than 3 months extent of lymph node involvement N1 vs N2-N3 interleukin-1 concentration in initial autologous lymphocyte culture less than 500 pgmL vs greater than 500 pgmL and prenephrectomy treatment
Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3 After cellular production the autologous lymphocytes are reinfused over at least 30 minutes Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 10-90 patients will accrued for this study within 3 years
Evaluate the ability of autologous lymphocyte therapy ALT given as adjuvant therapy following nephrectomy andor complete surgical resection of any metastatic disease to delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma
Determine the incidence of tumor recurrence and the survival of these patients treated with this regimen
Determine the toxicitymorbidity of this regimen in these patients
Explore the relationship between clinical response and in vitro autologous lymphocyte characteristics including lytic activity cytokine production response to cytokines and phenotypic profile in these patients treated with this regimen
Assess patient immune status before during and after therapy
OUTLINE Patients are stratified according to postnephrectomy interval less than 3 months vs more than 3 months extent of lymph node involvement N1 vs N2-N3 interleukin-1 concentration in initial autologous lymphocyte culture less than 500 pgmL vs greater than 500 pgmL and prenephrectomy treatment
Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3 After cellular production the autologous lymphocytes are reinfused over at least 30 minutes Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 10-90 patients will accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V94-0514 | None | None | None |
| STLMC-BRM-9401 | None | None | None |