Solid Tumor Maintenance Protocol – Phase II

AflacST1903: A Maintenance Protocol of Sirolimus in Combination with Metronomic Chemotherapy in Children with High-Risk Solid Tumors

Protocol Description

This multi-center study assesses the effectiveness of a new chemotherapy maintenance regimen to help prevent recurrence of a solid tumor that has gone into remission following treatment. The trial drugs are a combination of sirolimus, celecoxib, etoposide, and cyclophosphamide, which can help to stop tumor growth by preventing blood from reaching the tumor.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 30 years of age who were treated for a qualifying high-risk malignant solid tumor that is in complete remission. Such tumors may include metastatic/unresectable osteosarcoma, metastatic Ewing or Ewing-like sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcoma, desmoplastic small round cell tumor, malignant rhabdoid tumor.
Males and Females: Ages 1 through 30 years


The study drugs are given in 6-week cycles for up to 8 cycles. Sirolimus and celecoxib are administered daily throughout the cycle. In the first 3 weeks of the cycle, etoposide is also taken daily. In the latter 3 weeks of the cycle, cyclophosphamide is taken instead of etoposide. Physical examinations and imaging studies will also be conducted at specific intervals.
Visits: About 14 from the initial examination through the maintenance period for most study participants.
Duration: Up to 12 months of maintenance for most participants, who are followed for a total of 3 years.

Status: Open to Enrollment

Source(s) of Support

Emory University
Peach Bowl LegACy Fund

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: