Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
Study NCT ID:
NCT00022295
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2001-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenoxodiol in Treating Patients With Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C471183', 'term': 'phenoxodiol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-25', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.\n\nPURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.\n* Determine the steady-state pharmacokinetics of this drug in these patients.\n* Determine the tumor response in patients treated with this drug.\n\nOUTLINE: This is a multicenter, dose-escalation study.\n\nPatients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed at 4 weeks.\n\nPROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed solid tumor\n\n * Refractory to standard therapy OR\n * No standard therapy exists\n* No breast cancer\n* No active CNS metastases\n\n * Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Platelet count greater than 100,000/mm\\^3\n* WBC greater than 3,000/mm\\^3\n* Neutrophil count greater than 1,500/mm\\^3\n* Hemoglobin greater than 10 g/dL (9 g/dL for women)\n\nHepatic:\n\n* Bilirubin less than 1.2 mg/dL\n* Transaminases no greater than 3 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 1.4 mg/dL\n\nOther:\n\n* No active infection\n* No contraindication to the insertion of a vascular access device\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent systemic anticancer immunotherapy\n\nChemotherapy:\n\n* No concurrent systemic anticancer chemotherapy\n\nEndocrine therapy:\n\n* No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Concurrent localized radiotherapy for control of local disease complications allowed\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* Recovered from prior antineoplastic therapy\n* At least 4 weeks since prior investigational agents\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00022295', 'briefTitle': 'Phenoxodiol in Treating Patients With Refractory Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy', 'orgStudyIdInfo': {'id': 'CDR0000068802'}, 'secondaryIdInfos': [{'id': 'NOVOGEN-NV06-0024'}, {'id': 'CCF-4269'}, {'id': 'NCI-V01-1663'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'idronoxil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Graham Kelly, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'MEI Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kazia Therapeutics Limited', 'class': 'INDUSTRY'}}}}