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Temsirolimus, Irinotecan Hydrochloride, and Temozolomide in Treating Young Patients With Relapsed or Refractory Solid Tumors

2014-07-23 21:08:49 | BioPortfolio

Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and the best dose of temsirolimus when given together with irinotecan hydrochloride and temozolomide in treating young patients with recurrent or refractory solid tumors.

Description

OBJECTIVES:

Primary

- To estimate the maximum-tolerated dose or recommended phase II dose of temsirolimus administered in combination with irinotecan hydrochloride and temozolomide in children, adolescents, and young adults with recurrent or refractory solid tumors.

- To define and describe the toxicities of this regimen in these patients.

Secondary

- To preliminarily define the antitumor activity of this regimen in these patients.

- To collect preliminary data regarding the biologic effects of temsirolimus on proteins involved in signaling pathways of interest in these patients. (exploratory)

OUTLINE: This is a multicenter study, dose-escalation study of temsirolimus.

Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and irinotecan hydrochloride and oral temozolomide on days 1-5. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Some patients undergo bone marrow collection at baseline and during study for temsirolimus-induced changes in mTOR pathway proteins by flow cytometric analysis and immunoblotting.

After completion of study therapy, patients are followed up for 30 days.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

irinotecan hydrochloride, temozolomide, temsirolimus, laboratory biomarker analysis

Location

UAB Comprehensive Cancer Center
Birmingham
Alabama
United States
35294

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:49-0400

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