Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00038012
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2002-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'C537560', 'term': 'Jacobs syndrome'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013926', 'term': 'Thrombopoietin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2002-05-24', 'studyFirstSubmitQcDate': '2002-05-24', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': 'Continuous'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dose-intensified carboplatin', 'autologous cryopreserved platelets', 'thrombopoietin', 'Gynecologic malignancy'], 'conditions': ['Neoplasms, Gynecologic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved with ThromboSol and 2% DMSO in Patients with Gynecologic Malignancy Receiving Carboplatin'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Patients with gynecologic malignancy for whom treatment with carboplatin is indicated.\n* Age \\>/= 15 years.\n* Adequate hematologic, renal, and hepatic functions.\n* Life expectancy \\>/- 3 months. Karnofsky Performance Status \\>/= 80.\n* Signed informed consent form.\n\nEXCLUSION CRITERIA:\n\n* Patients with rapidly progressive disease.\n* Pregnant or lactating women.\n* Patients with comorbid condition which renders patients at high risk of treatment complication.\n* History of CNS metastasis.\n* Patients with significant cardiac disease (NYHA Class III or IV), dysrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the 6 months of study entry.\n* Prior chemotherapy, immunotherapy, any experimental drug within 4 weeks, use of myeloid (G-CSF or GM-CSF) growth factors within 2 weeks or erythropoietin within 4 weeks.\n* Use of any nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks.\n* Prior surgery or RT within 2 wks of study entry.\n* Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (\\> 2 weeks).\n* History of leukemia.\n* History of any platelet disorders including ITP, TTP or bleeding disorders.\n* History of \\> 3 prior chemotherapy regimens (all platinum regimens will be counted as 1 regimen).\n* Demonstrated lack of response to platinum-based therapy.'}, 'identificationModule': {'nctId': 'NCT00038012', 'briefTitle': 'rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving Carboplatin', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Pilot Study of Transfusion of rhTPO-Derived Autologous Platelets Cryopreserved With Thrombosol and 2% DMSO in Patients With Gynecologic Malignancy Receiving Carboplatin', 'orgStudyIdInfo': {'id': 'GYN97-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhTPO-Derived Autologous Platelets Transfusion', 'interventionNames': ['Drug: Thrombopoietin', 'Procedure: Platelet-pheresis', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Thrombopoietin', 'type': 'DRUG', 'armGroupLabels': ['rhTPO-Derived Autologous Platelets Transfusion']}, {'name': 'Platelet-pheresis', 'type': 'PROCEDURE', 'armGroupLabels': ['rhTPO-Derived Autologous Platelets Transfusion']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'armGroupLabels': ['rhTPO-Derived Autologous Platelets Transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Saroj Vadhan-Raj, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pharmacia', 'class': 'INDUSTRY'}, {'name': 'LifeCell', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}