Neutropenia, Sarcoma
Conditions
Keywords
Bone cancer, Sarcoma, Neutropenia, Chemotherapy
Brief summary
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.
Interventions
DRUGpegfilgrastim
pegfilgrastim
DRUGfilgrastim
filgrastim
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Sarcoma \* No previous chemotherapy or radiotherapy \* Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia in chemotherapy in cycles 1 and 3 | 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 | cycles 1 and 3 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile in chemotherapy cycles 1 and 3 | cycles 1 and 3 |
| Incidence of adverse events across all cycles of chemotherapy | all cycles |
| Overall rates of febrile neutropenia | all cycles |
Outcome results
None listed