Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj
Identifikohuni Regjistrohu
Lidhja ruhet në kujtesën e fragmenteve
StatusiPërfunduar
Sponsorët
Amgen
TRAJTIM KLINIKAL: NCT00035620
BioSeek: nct00035620
Fjalë kyçe
Abstrakt
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.
Datat
| Verifikuar së fundmi: | 01/31/2010 |
| Paraqitur së pari: | 05/02/2002 |
| Regjistrimi i vlerësuar u dorëzua: | 05/02/2002 |
| Postuar së pari: | 05/05/2002 |
| Përditësimi i fundit i paraqitur: | 02/24/2010 |
| Përditësimi i fundit i postuar: | 02/25/2010 |
| Data e fillimit të studimit aktual: | 03/31/2000 |
| Data e vlerësuar e përfundimit primar: | 12/31/2006 |
| Data e vlerësimit të përfundimit të studimit: | 03/31/2007 |
Gjendja ose sëmundja
Sarcoma
Neutropenia
Ndërhyrja / trajtimi
Drug: Pegfilgrastim
Drug: Filgrastim
Faza
Faza 2
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| Active Comparator: Filgrastim Filgrastim | Drug: Filgrastim filgrastim |
| Experimental: Pegfilgrastim Pegfilgrastim | Drug: Pegfilgrastim pegfilgrastim |
Kriteret e pranimit
| Gjinitë e pranueshme për studim | All |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | - Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna |
Rezultati
Masat Kryesore të Rezultateve
1. Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [cycles 1 and 3]
2. 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]
Masat dytësore të rezultateve
1. Pharmacokinetic profile in chemotherapy cycles 1 and 3 [cycles 1 and 3]
2. Incidence of adverse events across all cycles of chemotherapy [all cycles]
3. Overall rates of febrile neutropenia [all cycles]
