drugset / Trial / NCT00278369

Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer

NCT00278369

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with interleukin-2 may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer.

Timeline

Start
2005-04
Primary completion
2009-06
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic Intravenous
Subject denileukin diftitox Protein / enzyme biologic 6 ug/kg Intravenous
Subject denileukin diftitox Protein / enzyme biologic 9 ug/kg Intravenous

Indications