Solid Tumor or ALCL Treatment with Crizotinib and Conventional Chemotherapy – Phase I

Crizotinib in Combination with Conventional Chemotherapy for Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Protocol Description

This Children’s Oncology Group Phase I trial studies the effects of crizotinib given together with conventional chemotherapy in treating younger patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL). Crizotinib may stop tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Study Level: Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 1 to 21 years with relapsed or refractory solid tumors or ALCL, excluding central nervous system tumors.
Males and Females: Ages 1 to 21 years

Requirements

Study participants will be placed in one of two study arms. Participants will receive 2 oral doses of crizotinib each day for a 21-day cycle. Those enrolled in Part A of the study will also receive a venous infusion of topotecan and cyclophosphamide on days 1-5 of each cycle. Those in Part B will receive an infusion of vincristine, doxorubicin and dexrazoxane each treatment day. Participation may continue for up to 24 months, or 35 cycles of therapy.
Visits: Weekly during first cycle, then monthly in subsequent cycles, with periodic lab evaluations and scans
Duration: Up to 2 years if tumor is responding and patient has no dose-limiting side effects

Status: Open for Enrollment

Source(s) of Support

Children’s Oncology Group (Study ADVL1212)
National Cancer Institute

Additional Information

Study Description at National Institutes of Health

Primary Investigator

Jean Tersak, MD

Contact Information

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