Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-26 @ 6:10 PM
Study NCT ID:
NCT00024492
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2001-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'statusVerifiedDate': '2004-08', 'completionDateStruct': {'date': '2004-06'}, 'lastUpdateSubmitDate': '2011-06-02', 'studyFirstSubmitDate': '2001-09-17', 'studyFirstSubmitQcDate': '2001-09-17', 'lastUpdatePostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-09-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Liposome Encapsulated Mitoxantrone (LEM)', 'solid tumors'], 'conditions': ['Tumors']}, 'descriptionModule': {'briefSummary': 'Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy.\n\nLEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.', 'detailedDescription': 'OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LEM.\n\nII. Measure the blood pharmacokinetics of LEM following IV administration.\n\nIII. Observe any anti-tumor effects of LEM.\n\nPROTOCOL OUTLINE: This is an open-label study for patients with advanced and/or metastatic, histologically-documented solid tumors considered to be unresponsive to available conventional treatment.\n\nLEM will be administered IV over 45 minutes. At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level. Study drug administration will continue on an every 3-week schedule in the absence of progressive disease or unacceptable toxicity. A subsequent course of treatment may be administered at least 21 days after a prior LEM dose has been administered when study criteria are met.\n\nCohorts of 3 patients per dose level will be studied. This will be expanded to 6 if a DLT occurs, followed by a total of 6 patients at a possible MTD.\n\nPROJECTED ACCRUAL: It is expected that 21 to 30 patients will be entered into the study to determine the MTD: 3 per dose level, expanded to 6 if DLT occurs, followed by a total of 6 patients at a possible MTD. The dose level identified as the MTD may then be expanded up to 12 patients to permit additional safety assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '-Disease Characteristics-\n\nAdvanced (local and/or metastatic) histologically documented solid tumors\n\nDisease is not considered responsive to available conventional modalities or treatments\n\n-Prior/Concurrent Therapy-\n\nMust be fully recovered from acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline before most recent treatment)\n\nNo radiotherapy, treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for mitomycin or nitrosoureas)\n\nAt least 2 weeks after any prior surgery or hormonal therapy\n\nChronic toxicities of grade 1 from prior treatment are permitted\n\n-Patient Characteristics-\n\nECOG Performance status of 0-2\n\nMust be at least 18 years of age\n\nMust have the following clinical laboratory values: ANC at least 1,500/mm3; Platelets at least 100,000/mm3; Hemoglobin at least 10 g/dL; albumin at least 3.0 mg/dL; Serum creatinine at least 2.0 mg/dL; Total bilirubin not more than upper limit of normal; ALT, AST, and alkaline phosphatase not more than 1.5 x upper limit of normal; LVEF by MUGA scan greater than or equal to the lower limit of normal\n\nMust sign informed consent\n\nNo pregnant and/or nursing patients. Women of child-bearing potential must have negative serum or urine pregnancy test within 1 week prior to study entry. Sexually-active patients (both men and women) must use acceptable contraceptive methods.\n\nNo active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)\n\nNo active infection of any kind\n\nNo known HIV infection or viral hepatitis\n\nNo active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or congestive heart failure\n\nNo known CNS metastases\n\nNo patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication\n\nNo patients requiring immediate palliative treatment of any kind including surgery\n\nNo patients who have received a high-dose chemotherapy regimen with stem cell support in the previous 6 months\n\nNo patients who have received a cumulative anthracycline dose greater than 250 mg/m2 (doxorubicin equivalent)\n\nNo patients unwilling or unable to follow protocol requirements\n\nNo patients with known hypersensitivity to mitoxantrone or liposomes.'}, 'identificationModule': {'nctId': 'NCT00024492', 'briefTitle': 'Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'INSYS Therapeutics Inc'}, 'orgStudyIdInfo': {'id': 'LEM-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liposome Encapsulated Mitoxantrone (LEM)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Przemyslaw Twardowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope National Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'INSYS Therapeutics Inc', 'class': 'INDUSTRY'}}}}