A Phase 1 Study of Temsirolimus in Combination With Irinotecan and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
I. To estimate the maximum tolerated dose (MTD) or recommended Phase 2 dose and schedule of
temsirolimus administered in combination with irinotecan and temozolomide every three weeks
to children with recurrent or refractory solid tumors.
II. To define and describe the toxicities of this regimen in these patients.
I. To preliminarily define the antitumor activity of this regimen in these patients.
II. 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 or on days 1, 8, and 15 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
After completion of study therapy, patients are followed up for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose or recommended phase II dose
The descriptions and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for AE reporting.
COG Phase I Consortium
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Midwest Children's Cancer Center||Milwaukee, Wisconsin 53226|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Children's Hospital of Pittsburgh of UPMC||Pittsburgh, Pennsylvania 15213|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Children's Hospital of Alabama||Birmingham, Alabama 35233|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|Oregon Health and Science University||Portland, Oregon 97201|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Childrens Memorial Hospital||Chicago, Illinois 60614|
|Columbia University Medical Center||New York, New York 10032|
|University of Minnesota Medical Center-Fairview||Minneapolis, Minnesota 55455|
|C S Mott Children's Hospital||Ann Arbor, Michigan 48109|
|Riley Hospital for Children||Indianapolis, Indiana 46202|
|Childrens Hospital of Orange County||Orange, California 92868-3874|
|Mark O Hatfield-Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892|
|University of California San Francisco Medical Center-Parnassus||San Francisco, California 94143|
|COG Phase I Consortium||Arcadia, California 91006-3776|