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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT00035620
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Neutropenia Drug: pegfilgrastim Drug: filgrastim Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
Study Start Date : April 2000
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2007

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Filgrastim
Filgrastim
 Drug: filgrastim
filgrastim
Experimental: Pegfilgrastim
Pegfilgrastim
 Drug: pegfilgrastim
pegfilgrastim


Outcome Measures
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Primary Outcome Measures :
  1. Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: 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 [ Time Frame: cycles 1 and 3 ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ]
  2. Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ]
  3. Overall rates of febrile neutropenia [ Time Frame: all cycles ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035620


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00035620     History of Changes
Other Study ID Numbers: 990130
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010

Keywords provided by Amgen:
Bone cancer
Sarcoma
Neutropenia
Chemotherapy

Additional relevant MeSH terms:
Sarcoma
Neutropenia
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
 Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs