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Through this Children’s Oncology Group (COG) study, researchers are evaluating the effectiveness of drug pevonedistat (MLN4924) used along with two other drugs to fight recurrent tumors and tumors that will not respond to standard therapy. Pevonedistat, which has shown potential in the laboratory tests and in other tests, will be given in combination with temozolomide and irinotecan. As a Phase I cancer trial, this program evaluates the effects of the drug on tumors, as well as its side effects and how the body processes it. This study is an initiative of COG’s Pediatric Early Phase Clinical Trial Network of which UPMC Children’s Hospital of Pittsburgh is a part.
Subject to certain exclusion criteria, this study is enrolling participants, ages 6 months to 21 years, who have recurrent or refractory solid tumors, including central nervous system tumors and lymphoma, for which no standard therapy is available.
Males and Females: Ages 6 months to 21 years
Participants will be given intravenous (IV) infusions of the study drugs at specified intervals during treatment cycles. The first cycle is 4 weeks, and subsequent cycles are 3 weeks. In addition to the IV infusions, study participants will have tests and procedures such as imaging and blood draws, as well as physical examinations at specific intervals.
Visits: 6 visits during the 3-week cycles for the IV infusions and medical evaluation
Duration: Up to 12 months or 17 cycles of therapy
Children’s Oncology Group (ADVL1615)
National Cancer Institute
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
Jean Tersak, MD
For more information about the study or enrollment, please contact:
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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