search
Back to results

Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Primary Purpose

Sarcoma, Neutropenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pegfilgrastim
filgrastim
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcoma focused on measuring Bone cancer, Sarcoma, Neutropenia, Chemotherapy

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Filgrastim

    Pegfilgrastim

    Arm Description

    Filgrastim

    Pegfilgrastim

    Outcomes

    Primary Outcome Measures

    Duration of severe neutropenia in chemotherapy in 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

    Secondary Outcome Measures

    Pharmacokinetic profile in chemotherapy cycles 1 and 3
    Incidence of adverse events across all cycles of chemotherapy
    Overall rates of febrile neutropenia

    Full Information

    First Posted
    May 3, 2002
    Last Updated
    February 25, 2010
    Sponsor
    Amgen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00035620
    Brief Title
    Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
    Official Title
    A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2000 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcoma, Neutropenia
    Keywords
    Bone cancer, Sarcoma, Neutropenia, Chemotherapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Filgrastim
    Arm Type
    Active Comparator
    Arm Description
    Filgrastim
    Arm Title
    Pegfilgrastim
    Arm Type
    Experimental
    Arm Description
    Pegfilgrastim
    Intervention Type
    Drug
    Intervention Name(s)
    pegfilgrastim
    Intervention Description
    pegfilgrastim
    Intervention Type
    Drug
    Intervention Name(s)
    filgrastim
    Intervention Description
    filgrastim
    Primary Outcome Measure Information:
    Title
    Duration of severe neutropenia in chemotherapy in cycles 1 and 3
    Time Frame
    cycles 1 and 3
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic profile in chemotherapy cycles 1 and 3
    Time Frame
    cycles 1 and 3
    Title
    Incidence of adverse events across all cycles of chemotherapy
    Time Frame
    all cycles
    Title
    Overall rates of febrile neutropenia
    Time Frame
    all cycles

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_990130.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.neulasta.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

    We'll reach out to this number within 24 hrs