Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Study Details
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.
Protocol Summary
Duration of severe neutropenia in chemotherapy in cycles 1 and 3
Timeframe: cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
Timeframe: cycles 1 and 3
Pharmacokinetic profile in chemotherapy cycles 1 and 3
Timeframe: cycles 1 and 3
Incidence of adverse events across all cycles of chemotherapy
Timeframe: all cycles
Overall rates of febrile neutropenia
Timeframe: all cycles