Lymphocyte Therapy in Treating Patients With Kidney Cancer

Phase 2

• Conditions: Kidney Cancer

• Registration Number: NCT00002589
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 1994-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States