Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-22 @ 1:13 AM
Study NCT ID:
NCT03250520
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2017-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2017-06-10', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the quality of life using the PedsQL Cancer Module©', 'timeFrame': 'Preoperative and at 1.3, 6, 12, 18 and 24 months.', 'description': 'Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©'}, {'measure': 'Change in tumor size', 'timeFrame': 'Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.', 'description': 'Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Tumor, Pediatric, Brainstem Glioma', 'Brain Tumor, Pediatric, Recurrent']}, 'descriptionModule': {'briefSummary': 'This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.\n* Indication of palliative surgical treatment by neurosurgery.\n* Good general condition, enabling the realization of surgical treatment.\n* Scale Lansky \\> 20)\n* conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.\n\nExclusion Criteria:\n\n* Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.\n* Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.\n* Patients with surgical complications prior to placement of the NPt-Ca.\n* Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.\n* Patient whose neurological condition do not allow the implementation of MRI without anesthesia.'}, 'identificationModule': {'nctId': 'NCT03250520', 'briefTitle': 'Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Infantil de Mexico Federico Gomez'}, 'officialTitle': 'Pilot Study of the Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial Platinum Acetylacetonate (1% wt) Supported by Sol-gel Technology Functionalized Titania (NPt-Ca)', 'orgStudyIdInfo': {'id': 'HIM 2017-072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glioma brain stem', 'interventionNames': ['Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania']}, {'type': 'EXPERIMENTAL', 'label': 'high grade recurrent brain tumor in the central nervous system', 'interventionNames': ['Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania']}], 'interventions': [{'name': 'Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania', 'type': 'DRUG', 'otherNames': ['Pt(acac)2/Titanium dioxide (Ti02)', 'Pt(acac)2/F-TiO2', 'NPt', 'NPt-Ca'], 'description': 'Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.', 'armGroupLabels': ['glioma brain stem', 'high grade recurrent brain tumor in the central nervous system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'DF', 'country': 'Mexico', 'facility': 'Hospital Infantil de Mexico Federico Gomez'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Infantil de Mexico Federico Gomez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher in the Neurology Department', 'investigatorFullName': 'Daniel Eduardo Alvarez Amado', 'investigatorAffiliation': 'Hospital Infantil de Mexico Federico Gomez'}}}}