NCT00087022

Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer

A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 864 (actual)
• Sponsor: Heidelberg Pharma AG · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer. PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 (WX-G250) vs placebo in an adjuvant setting. Secondary * Evaluate the safety of these drugs in these patients. * Assess the quality of life of patients treated with this drug. * Perform pharmacokinetic analysis of WX-G250. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk criteria and participating centers (US vs Non-US). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes once weekly for 24 weeks. * Arm II: Patients receive placebo IV over 15 minutes once weekly for 24 weeks. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Blood samples are collected for pharmacokinetic analysis. Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6 months after completion of study treatment. Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and 4, and then annually during year 5 and thereafter. PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm) were accrued for this trial.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	girentuximab	Given IV
OTHER	placebo	Given IV

Timeline

• Start date: 2004-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2004-07-12
• Last updated: 2018-11-27
• Results posted: 2018-09-12

Locations

56 sites across 4 countries: United States, Argentina, Brazil, Canada