Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
- 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.
Primary Purpose: Treatment
Survival as measured by Kaplan-Meier method at 5 years
John P. Hanson, MD
St. Luke's Medical Center
United States: Federal Government
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|