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Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035620
First Posted: May 6, 2002
Last Update Posted: February 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
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 Intervention Phase
Sarcoma Neutropenia Drug: pegfilgrastim Drug: filgrastim Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

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

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

Enrollment: 44
Study Start Date: April 2000
Study Completion Date: April 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Filgrastim
Filgrastim
Drug: filgrastim
filgrastim
Experimental: Pegfilgrastim
Pegfilgrastim
Drug: pegfilgrastim
pegfilgrastim

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00035620     History of Changes
Other Study ID Numbers: 990130
First Submitted: May 3, 2002
First Posted: May 6, 2002
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