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SELECT: High-Dose IL-2 in mRCC

NCT00554515Phase 2

Key facts

Status: Completed
Start: Nov 2006
Primary completion: Oct 2013
Countries: 1
Sponsor: Beth Israel Deaconess Medical Center
Modality: Cytokines & Interferons

Drugs: aldesleukin
Conditions: metastatic renal cell carcinoma (mRCC)

Overview

Phase 2, open-label, single-arm trial of aldesleukin in metastatic renal cell carcinoma (mRCC), sponsored by Beth Israel Deaconess Medical Center. Primary endpoint: Objective Response in ISM Good Risk Group at 12 weeks. Started Nov 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

High-Dose IL-2
Aldesleukin 600,000 IU/kg/dose i.v. every 8 hours for up to 14 doses per cycle.

Who it enrols

Patients with histologically confirmed metastatic or unresectable renal cell carcinoma, good performance status, and adequate organ function. Excludes patients with prior systemic therapy for metastatic disease or organ allografts.

Endpoints

Primary

Objective Response in ISM Good Risk Group12 weeks

Secondary

Objective Response Rate in ISM Poor Risk Group12 weeks
Objective Response Rate (Independent Assessment)12 weeks
Overall Survival7 years
3-Year Progression-Free Survival Rate3 years
Objective Response Rate by MSKCC Risk Group12 weeks
Objective Response Rate by UCLA SANI Score12 weeks
Objective Response Rate by Tumor Type12 weeks
Objective Response Rate by Clear Cell Histology Risk Group12 weeks

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