Sirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title: A Pharmacodynamic Study of Sirolimus in Older Children and Adults With Advanced Solid Malignancies

Status Completed

Clinical Trial Summary

This clinical trial studies sirolimus in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To describe the magnitude, inter-individual variability and time course of sirolimus-induced changes in fasting serum glucose and triglycerides.

SECONDARY OBJECTIVES:

I. To assess candidate genetic variants for their correlation with changes in fasting glucose and/or triglycerides.

II. To assess tumor response by the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) and explore whether there is any correlation between response and changes in fasting glucose and/or triglycerides.

III. To assess toxicity by the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) and explore whether there is any correlation between toxicities and changes in fasting glucose and/or triglycerides.

IV. To quantify and determine the functional status of circulating regulatory T cells (Tregs) before and during treatment.

OUTLINE:

Patients receive sirolimus orally (PO) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ;

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

• NCT number: NCT01791088
• Study type: Interventional
• Source: University of Chicago
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2012
• Completion date: August 17, 2018