Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT00035620
Status:
COMPLETED
Last Update Posted:
2010-02-26
First Post:
2002-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-25', 'studyFirstSubmitDate': '2002-05-03', 'studyFirstSubmitQcDate': '2002-05-03', 'lastUpdatePostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of severe neutropenia in chemotherapy in cycles 1 and 3', 'timeFrame': 'cycles 1 and 3'}, {'measure': 'Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3', 'timeFrame': 'cycles 1 and 3'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile in chemotherapy cycles 1 and 3', 'timeFrame': 'cycles 1 and 3'}, {'measure': 'Incidence of adverse events across all cycles of chemotherapy', 'timeFrame': 'all cycles'}, {'measure': 'Overall rates of febrile neutropenia', 'timeFrame': 'all cycles'}]}, 'conditionsModule': {'keywords': ['Bone cancer', 'Sarcoma', 'Neutropenia', 'Chemotherapy'], 'conditions': ['Sarcoma', 'Neutropenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_990130.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.neulasta.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Sarcoma \\* No previous chemotherapy or radiotherapy \\* Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna'}, 'identificationModule': {'nctId': 'NCT00035620', 'briefTitle': 'Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients', 'orgStudyIdInfo': {'id': '990130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Filgrastim', 'description': 'Filgrastim', 'interventionNames': ['Drug: filgrastim']}, {'type': 'EXPERIMENTAL', 'label': 'Pegfilgrastim', 'description': 'Pegfilgrastim', 'interventionNames': ['Drug: pegfilgrastim']}], 'interventions': [{'name': 'pegfilgrastim', 'type': 'DRUG', 'description': 'pegfilgrastim', 'armGroupLabels': ['Pegfilgrastim']}, {'name': 'filgrastim', 'type': 'DRUG', 'description': 'filgrastim', 'armGroupLabels': ['Filgrastim']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}