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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00035620
First received: May 3, 2002
Last updated: February 25, 2010
Last verified: February 2010
History of Changes

May 3, 2002
February 25, 2010
April 2000
January 2007   (final data collection date for primary outcome measure)
  • Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
  • Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00035620 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
  • Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
  • Overall rates of febrile neutropenia [ Time Frame: all cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sarcoma
  • Neutropenia
  • Drug: pegfilgrastim
    pegfilgrastim
  • Drug: filgrastim
    filgrastim
    Other Name: filgrastim
  • Active Comparator: Filgrastim
    Filgrastim
    Intervention: Drug: filgrastim
  • Experimental: Pegfilgrastim
    Pegfilgrastim
    Intervention: Drug: pegfilgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2007
January 2007   (final data collection date for primary outcome measure)
  • Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00035620
990130
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP