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

NCT00087022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 864

Last updated 2018-11-27

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

girentuximab

Given IV

OTHER

placebo

Given IV

Sponsors & Collaborators

  • Heidelberg Pharma AG

    lead INDUSTRY

Principal Investigators

  • Pia Kloepfer, MD · Heidelberg Pharma AG

  • Arie Belldegrun, MD, FACS · Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00087022 on ClinicalTrials.gov