Solid Tumor Treatment with MLN4924, Temozolomide and Irinotecan – Phase I

Study of Pevonedistat (MLN4924), a NEDD8-Activating Enzyme Inhibitor, in Combination with Temozolomide and Irinotecan in Pediatric Patients with Recurrent or Refractory Solid Tumors

Protocol Description

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.

Study Level: Phase I

Eligibility Criteria

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

Requirements

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

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1615)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski
412-692-5055