Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-26 @ 1:34 PM
Study NCT ID:
NCT00776867
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C105905', 'term': 'perifosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2008-10-20', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of perifosine monotherapy in children with cancer', 'timeFrame': 'conclusion of the study'}], 'secondaryOutcomes': [{'measure': 'To determine whether pharmacokinetic serum levels correlate with toxicity', 'timeFrame': 'conclusion of the study'}, {'measure': 'If previously resected tissue is available, determine whether molecular features predict response including Elevated PI3K/AKT/mTOR signaling, Elevated RAS/MAPK signaling, Cell cycle markers', 'timeFrame': 'conclusion of the study'}]}, 'conditionsModule': {'keywords': ['Pediatric', 'solid tumors', 'Pediatric solid tumors', '08-091'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '27649927', 'type': 'DERIVED', 'citation': 'Kushner BH, Cheung NV, Modak S, Becher OJ, Basu EM, Roberts SS, Kramer K, Dunkel IJ. A phase I/Ib trial targeting the Pi3k/Akt pathway using perifosine: Long-term progression-free survival of patients with resistant neuroblastoma. Int J Cancer. 2017 Jan 15;140(2):480-484. doi: 10.1002/ijc.30440. Epub 2016 Sep 30.'}, {'pmid': '22419878', 'type': 'DERIVED', 'citation': 'Sun W, Modak S. Emerging treatment options for the treatment of neuroblastoma: potential role of perifosine. Onco Targets Ther. 2012;5:21-9. doi: 10.2147/OTT.S14578. Epub 2012 Mar 2.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether perifosine- a drug that inhibits the protein AKT, and has had some success in the treatment of adult cancers- is safe and effective in treating cancer. The investigators want to find out what effects, good and/or bad, it has on the patient and the cancer. The investigators are testing different dose schedules of perifosine and the patient will be asked to partake in one of the dose schedules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any solid tumor that failed standard therapy.\n* Patient must have evidence for tumor by CT, MRI, PET scan, MIBG scan, serum markers, or tissue sampling.\n* Age ≤ 21 years.\n* Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age\\> 16 years and Lansky score for age ≤ 16 years)\n* ANC≥ 1000 at least 24 hours off GCSF\n* Platelets ≥ 75k at least one week off platelet transfusions\n* Hg≥ 8g/dL at least one week off PRBC transfusion\n* AST ≤ 3 x the upper limit of normal\n* ALT ≤ 3 x the upper limit of normal\n* Total bilirubin ≤ 2.0 mg/dl\n* serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.\n* ≥ 3 weeks since last non-nitrosourea chemotherapy\n* ≥ 6 weeks since last nitrosoureas\n* ≥ 4 weeks since last RT\n* Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to drug initiation. Females must not be breast feeding.\n* Patients must be able to swallow tablets whole\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients must not have active infection or serious intercurrent medical illness.\n* HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.\n* Patients must not be taking EIAEDs. If patients were previously EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.'}, 'identificationModule': {'nctId': 'NCT00776867', 'briefTitle': 'Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase I Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors', 'orgStudyIdInfo': {'id': '08-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'perifosine', 'description': 'This will be a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3-6 patients at each dose level.', 'interventionNames': ['Drug: perifosine']}], 'interventions': [{'name': 'perifosine', 'type': 'DRUG', 'description': "Open label, phase I study of oral perifosine in recurrent/progressive pediatric solid tumors. This will be a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3-6 patients at each dose level. All patients will receive perifosine at a loading dose on the first day, followed by a maintenance dose to start on day two until progression each patient will be assigned to a dosing group based on one's body surface area (BSA).", 'armGroupLabels': ['perifosine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ira Dunkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'AEterna Zentaris', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}