Study of Combination of Sirolimus and Sutent in Patients With Advanced Solid Tumors Non-Curable With Standard Therapy

Tumors Clinical Trial

Official title: A Phase I Trial of the Combination of Sirolimus and SU11248 (Sutent(R)) in Patients With Advanced Solid Tumors That Are Non-Curable With Standard Therapy

Status Terminated

Clinical Trial Summary

There are two drugs involved in this study. Sunitinib (Sutent(R)) is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell (kidney) cancer and gastrointestinal stromal tumors. Sunitinib is thought to work by blocking the growth of blood vessels into tumors; reducing the blood supply to tumors can slow their growth and sometimes causes the tumors to shrink. Sirolimus has been approved by the FDA to prevent the body from rejecting organ transplants. Sirolimus is being tested for its effects against cancer because it can slow the growth of some tumors in animal models. Sirolimus is thought to slow cancer growth in these animal models both by direct effects on the tumor cells, and also by blocking production of growth factors that stimulate production of blood vessels. We hope that the combined use of these two drugs will have better anti-cancer effects than either agent alone. This study is designed to find out if different doses of Sirolimus combined with a standard dose of Sutent are safe and well tolerated. Additionally, it is hoped to gain knowledge about the way that Sutent(R) in combination with sirolimus affects the blood vessels produced by cancer.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

• NCT number: NCT00402415
• Study type: Interventional
• Source: Yale University
• Status: Terminated
• Phase: Phase 1
• Start date: February 2006
• Completion date: July 2008