Lymphocyte Therapy in Treating Patients With Kidney Cancer
Recruitment status was: Active, not recruiting
RATIONALE: Treating a person's 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.
|Kidney Cancer||Biological: aldesleukin Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Procedure: adjuvant therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma|
- Survival as measured by Kaplan-Meier method at 5 years
- Onset of recurrence as measured by Kaplan-Meier method at 5 years
- Safety as measured by NCI Common Toxicity Criteria at completion of study
|Study Start Date:||July 1994|
- Evaluate the ability of autologous lymphocyte therapy (ALT) given as adjuvant therapy following nephrectomy and/or 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 toxicity/morbidity 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 pg/mL vs greater than 500 pg/mL), 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002589
|United States, Wisconsin|
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53201-2901|
|Study Chair:||John P. Hanson, MD||St. Luke's Medical Center|