Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
Amgen
JARIBIO LA KLINIKI: NCT00035620
BioSeek: nct00035620
Maneno muhimu
Kikemikali
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.
Tarehe
| Imethibitishwa Mwisho: | 01/31/2010 |
| Iliyowasilishwa Kwanza: | 05/02/2002 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 05/02/2002 |
| Iliyotumwa Kwanza: | 05/05/2002 |
| Sasisho la Mwisho Liliwasilishwa: | 02/24/2010 |
| Sasisho la Mwisho Lilichapishwa: | 02/25/2010 |
| Tarehe halisi ya kuanza kwa masomo: | 03/31/2000 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 12/31/2006 |
| Tarehe ya Kukamilisha Utafiti: | 03/31/2007 |
Hali au ugonjwa
Sarcoma
Neutropenia
Uingiliaji / matibabu
Drug: Pegfilgrastim
Drug: Filgrastim
Awamu
Awamu 2
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Filgrastim Filgrastim | Drug: Filgrastim filgrastim |
| Experimental: Pegfilgrastim Pegfilgrastim | Drug: Pegfilgrastim pegfilgrastim |
Vigezo vya Kustahiki
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | - Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna |
Matokeo
Hatua za Matokeo ya Msingi
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]
Hatua za Matokeo ya Sekondari
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]
