Research

Osteosarcoma Combination Treatment Study - Phase III

Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

Protocol Description

The purpose of this Children's Oncolgy Group Phase III trial, focused on patients with osteosarcoma, is to study the effectiveness of combination chemotherapy followed by surgery and two different combination chemotherapy regimens – with or without PEG-interferon alfa-2b – to compare how well they work.

Eligibility Criteria

The group-wide study is accepting male and female patients, aged 5 to 40, with histologically-confirmed high-grade osteosarcoma, including second malignancies. Children’s Hospital of Pittsburgh of UPMC will enroll children and young adults who meet program criteria.
Boys: Age 5 and up
Girls: Age 5 and up

Requirements
Participants enrolled in the study will undergo chemotherapy using the standard anti-cancer regimen followed by surgery and assessment of the histologic response. Participants are then separated into those that had good histologic response and poor histologic response and those groups will be randomly split for further chemotherapy using standard or experimental regimens.
Visits: Multiple, including hospitalization for surgery.
Duration: Depending on outcomes and group assignment, treatment may range from 10 months to 2 years.

Status: Open for Enrollment

Source of Support
Children’s Oncology Group (Study AOST0331)
National Cancer Institute
Schering–Plough

Additional Resources
Children’s Oncology Group CureSearch
Study Description at National Institutes of Health