Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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)|
- Disease-free survival [ Time Frame: Local 360 DFS events ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later ] [ Designated as safety issue: No ]
- Quality of life by EORTC Quality of Life Questionnaire-C30 at 3, 6, and 12 months [ Time Frame: At final analysis ] [ Designated as safety issue: No ]
- Safety by NCI CTCAE v3.0 at 1 month following study treatment [ Time Frame: At final analysis ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of WX-G250 [ Time Frame: At final analysis ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes once weekly for 24 weeks.
Placebo Comparator: Arm II
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
- 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.
- 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.
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|Study Director:||Pia Kloepfer, MD||Wilex|
|Principal Investigator:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|