Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-29 @ 10:57 PM
Study NCT ID:
NCT01614132
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2012-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060046', 'term': 'Maintenance Chemotherapy'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D008130', 'term': 'Lomustine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of the adjuvant chemotherapy', 'timeFrame': 'participants will be followed for the duration of chemo therapy, an expected average of 1 year', 'description': 'The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far.\n\nThe present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .'}], 'secondaryOutcomes': [{'measure': 'Number of performable cycles in chemo therapy', 'timeFrame': 'participants will be followed for the duration of chemo therapy, an expected average of 6 months', 'description': 'It should be determined how many cycles in the maintenance chemotherapy are feasible.'}, {'measure': '3 and 5 years progression-free survival', 'timeFrame': 'participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years', 'description': 'The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.'}, {'measure': 'event-free survival', 'timeFrame': 'participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years', 'description': 'The event-free survival (efs) should be determined for adult patients.'}, {'measure': 'overall survival', 'timeFrame': 'participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years', 'description': 'The overall survival (os) should be determined for adult patients.'}, {'measure': 'course of cognitive performance/QoL', 'timeFrame': 'participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years', 'description': 'The course of the cognitive performance and the quality of life should be observed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medulloblastoma', 'CNS', 'malignant neoplasm', 'NOA', 'neuroectodermal tumor', 'Vincristin', 'CCNU', 'Cisplatin'], 'conditions': ['Medulloblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.', 'detailedDescription': 'As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 18 years\n* medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively\n* primary diagnosis of the tumor\n* no previous chemo- or radiation therapy\n* Karnofsky-Index ≥ 70%\n* WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl\n* creatinine =\\< 1,5 ULN; Bilirubin =\\< 1,5 ULN; GPT, GOT, AP =\\< 2,5 ULN\n* HIV and hepatitis B/C negative\n* no factors / any medical condition affecting patient's compliance\n* patient needs to fulfil protocol's requirements\n* patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks\n* patient's written consent\n\nExclusion Criteria:\n\n* age \\< 18 years\n* histologically not confirmed Medulloblastoma\n* by chemo- or radiotherapy treated recidive tumor\n* other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)\n* hypersensitivity or contraindication against one of the used drugs\n* current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study\n* Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert\n* Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception"}, 'identificationModule': {'nctId': 'NCT01614132', 'acronym': 'NOA-07', 'briefTitle': 'Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)', 'orgStudyIdInfo': {'id': 'NOA-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vincristin, CCNU, cis-platin', 'description': 'radiotherapy and concomitant chemotherapy (7 cycles of 7 days):\n\n* 2 mg/m2 vincristin i.v.\n* 55,0 Gy Posterior cranial fossa (M0)\n* 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3)\n\nmaintenance chemotherapy (8 cycles of 42 days):\n\n* once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v.\n* once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v.', 'interventionNames': ['Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'maintenance chemotherapy (vincristin, cisplatin and CCNU)', 'type': 'DRUG', 'otherNames': ['Vincristin: L01CA02', 'CCNU: Lomustin L01AD02', 'cis-platin: L01XA01'], 'description': 'maintenance chemotherapy of maximum of 8 cycles á 42 days', 'armGroupLabels': ['Vincristin, CCNU, cis-platin']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy of the partial brain', 'armGroupLabels': ['Vincristin, CCNU, cis-platin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Netzwerk für Gesundheit GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Neurologische Universitätsklinik', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Otto-von-Guericke Universität', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Katharinenhospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Peter Hau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Regensburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Clinical Neurooncology', 'investigatorFullName': 'Peter Hau', 'investigatorAffiliation': 'University of Regensburg'}}}}