Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00001502
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}], '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': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C089876', 'term': 'RMP 7'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-02', 'completionDateStruct': {'date': '2000-03'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '2002-12-09', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Blood-Brain Barrier', 'Bradykinin', 'Children', 'Glioma', 'Medulloblastoma'], 'conditions': ['Brain Neoplasms', 'Glioma', 'Medulloblastoma']}, 'referencesModule': {'references': [{'pmid': '8187947', 'type': 'BACKGROUND', 'citation': 'Clements JA. The human kallikrein gene family: a diversity of expression and function. Mol Cell Endocrinol. 1994 Feb;99(1):C1-6. doi: 10.1016/0303-7207(94)90138-4. No abstract available.'}, {'pmid': '7870689', 'type': 'BACKGROUND', 'citation': 'Straub JA, Akiyama A, Parmar P. In vitro plasma metabolism of RMP-7. Pharm Res. 1994 Nov;11(11):1673-6. doi: 10.1023/a:1018986510570. No abstract available.'}, {'pmid': '7931623', 'type': 'BACKGROUND', 'citation': 'Inamura T, Nomura T, Bartus RT, Black KL. Intracarotid infusion of RMP-7, a bradykinin analog: a method for selective drug delivery to brain tumors. J Neurosurg. 1994 Nov;81(5):752-8. doi: 10.3171/jns.1994.81.5.0752.'}]}, 'descriptionModule': {'briefSummary': 'The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.', 'detailedDescription': 'The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nHistologically confirmed brain tumor including but not limited to the following: Anaplastic astrocytoma, Glioblastoma multiforme, Low-grade glioma, Ependymoma, Medulloblastoma, Pineal tumors, Chiasmal glioma, Craniopharyngioma, Brain stem glioma (requirement for histologic diagnosis may be waived).\n\nDisease refractory to standard therapy or no standard chemotherapy exists and ineligible for potential curative surgery or radiotherapy.\n\nMeasurable or evaluable disease on radiographic studies with evidence of progression on prior chemotherapy or radiotherapy or persistent disease after surgery.\n\nPRIOR/CURRENT THERAPY:\n\nSee Disease Characteristics\n\nAt least 6 months since carboplatin.\n\nAt least 3 weeks since myelosuppressive therapy.\n\nPatients who received stem cell or bone marrow rescue after nitrosourea therapy are eligible after 3 weeks if they have recovered from hematologic toxicities of their prior therapy.\n\nConcurrent steroids allowed if dose stable for at least 2 weeks prior to entry.\n\nRecovered from toxic effects of any prior therapy.\n\nPATIENT CHARACTERISTICS:\n\nAge: 21 and under.\n\nPerformance status: ECOG 0-2.\n\nLife expectancy: At least 8 weeks.\n\nHEMATOLOGIC:\n\nAbsolute granulocyte count greater than 1,500/mm(3).\n\nPlatelet count greater than 100,000/mm(3) (at least 75,000/mm(3) in patients with prior bone marrow transplantation or craniospinal irradiation).\n\nHemoglobin greater than 8.0 g/dL.\n\nHEPATIC:\n\nBilirubin no greater than 2 times normal.\n\nALT no greater than 2 times normal.\n\nRENAL:\n\nCreatinine within normal limits for age as follows:\n\nAge (in years) -- Creatinine (in mg/dL):\n\nYounger than 5 -- no greater than 1.2;\n\n5-10 -- no greater than 1.5;\n\n10-15 -- no greater than 1.8;\n\nOlder than 15 -- no greater than 2.4.\n\nOTHER:\n\nNo significant systemic illness.\n\nNo pregnant or nursing women.\n\nNegative pregnancy test required of fertile women.\n\nEffective contraception required of fertile patients.\n\nDurable power of attorney required of all patients 18-21 years of age.'}, 'identificationModule': {'nctId': 'NCT00001502', 'briefTitle': 'A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors', 'orgStudyIdInfo': {'id': '960068'}, 'secondaryIdInfos': [{'id': '96-C-0068'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'RMP-7 and carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}