Last updated on February 2018

Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children

Brief description of study

This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia.

Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved for the disease being treated in this study. Since carfilzomib has not yet been used in this setting to treat this condition, the investigators must first find the best dose to give. The investigators are looking for the highest dose of carfilzomib that can be given safely. Therefore, not all children taking part in this study will receive the same dose of the study drug in the first part of the trial.

Detailed Study Description

The purpose of this study is to find out what effects, good and/or bad, treatment with a new combination of drugs, cyclophosphamide, etoposide, and carfilzomib has on cancer.

In part 1 of the trial, small groups of children will be enrolled in steps. The first group will be given a certain dose of carfilzomib. If these children do not have side effects which are too bad, the next small group of children enrolled will receive a higher dose. This increase in doses with groups of people will continue until we find the highest dose of the drug that can be given without causing severe or unmanageable side effects.

Part 2 of this study will enroll additional patients at the highest tolerable dose found in Part 1 in order to get more information on side effects and make sure the dose is tolerable.

Clinical Study Identifier: NCT02512926

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Jessica Boklan, MD

Phoenix Children's Hospital
Phoenix, AZ United States
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Kathleen Neville, MD, MS

Arkansas Children's Hospital
Little Rock, AR United States
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Norman Lacayo, MD

Stanford University School of Medicine and Stanford Cancer Institute
Palo Alto, CA United States
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Steven DuBois, MD

Dana Farber Cancer Institute
Boston, MA United States
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Tanya Trippett, MD

Memorial Sloan-Kettering Cancer Center
New York, NY United States
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Valerie Brown, MD, PhD

Penn State Hershey Children's Hospital
Hershey, PA United States
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Anne Franklin, MD

MD Anderson Cancer Center
Houston, TX United States
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Anne-Marie Langevin, MD

University of Texas Health Science Center at San Antonio
San Antonio, TX United States
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Aru Narendran, MD, PhD

Alberta Children's Hospital
Calgary, AB Canada
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Recruitment Status: Open

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