Solid Tumor Treatment with MK-1775 – Phase I/II

MK-1775 in Combination with Oral Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors

Protocol Description

The goal of this multicenter trial by the Children’s Oncology Group is to determine the effects and efficacy of AZD1775 (MK-1775) in combination with irinotecan for treatment of relapsed or refractory solid tumors. Adult cancer studies have demonstrated that MK-1775 be safely added to standard chemotherapy regimens to with the goal of increasing effectiveness, This study combines MK-1775 with irinotecan, which is an active chemotherapy agent against a variety of pediatric cancers.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders ages 1 to 21, who have been diagnosed as having relapsed or refractory solid tumors, neuroblastoma, medulloblastoma or central nervous system primitive neuroectodermal tumor (PNET).
Males and Females: Ages 1 to 21

Requirements

Patients enrolled in the study will be given oral doses of MK-1775 along with irinotecan for the first 5 days of a 21-day cycle. Patients may continue to receive the study drugs for up to 18 cycles, unless serious side effects occur or the tumor worsens.
Visits: 4 for the first month, with weekly labwork, then monthly with weekly labwork in patients who remain on study
Duration: Up to 54 weeks, depending on outcomes

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1312)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864