Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT00019656
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105905', 'term': 'perifosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-08', 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV chronic lymphocytic leukemia', 'refractory chronic lymphocytic leukemia', 'unspecified adult solid tumor, protocol specific', 'previously treated myelodysplastic syndromes', 'de novo myelodysplastic syndromes', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult Burkitt lymphoma', 'recurrent adult Hodgkin lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'secondary myelodysplastic syndromes', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage IV adult Burkitt lymphoma', 'stage IV adult Hodgkin lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'stage IV adult lymphoblastic lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV mantle cell lymphoma', 'chronic myelomonocytic leukemia', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'myelodysplastic/myeloproliferative neoplasm, unclassifiable', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'stage IV small lymphocytic lymphoma', 'stage IV marginal zone lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma'], 'conditions': ['Leukemia', 'Lymphoma', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Monga M, Messmann RA, Headlee D, et al.: A phase I trial of oral perifosine in patients with refractory neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1837, 7b, 2002.'}, {'type': 'RESULT', 'citation': 'Messmann RA, Headlee D, Woo EW, et al.: A phase I trial of oral perifosine with different loading and maintenance schedules in patients with refractory neoplasms. [Abstract] Proc Am Assoc Cancer Res 42: A-2880, 2001.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.', 'detailedDescription': "OBJECTIVES:\n\n* Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma.\n* Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen.\n* Determine any disease responses that may occur in patients treated with this regimen.\n* Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.\n\nCohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each 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. Once the MTD is determined, an additional 10 patients are treated at that dose level.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy\n* No history of CNS neoplasms\n* For prostate cancer:\n\n * Tumor progression during blockade of testicular and adrenal androgens\n * At least 4 weeks since prior flutamide or other antiandrogens without disease improvement\n * Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy\n * Testosterone in the castrate range\n* For breast cancer:\n\n * At least 4 weeks since any prior hormonal therapy with evidence of disease progression\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Platelet count greater than 50,000/mm\\^3\n* Absolute granulocyte count greater than 500/mm\\^3\n* Hemoglobin at least 9.0 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT and SGPT no greater than 2.5 times normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No history of unstable or newly diagnosed angina pectoris\n* No myocardial infarction within the past 6 months\n* No New York Heart Association class II-IV heart disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption\n* No allergic reaction to any medication with a structure similar to perifosine\n* No pre-existing retinal disease or pathologic baseline electrooculogram\n* No cataracts that would interfere with normal vision or require medical intervention\n* No other serious concurrent illness that would preclude assessment of drug effect\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n* At least 2 months since prior UCN-01\n* More than 3 months since prior suramin\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent corticosteroids except for physiological replacement or as antiemetics\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No other concurrent antineoplastic therapies"}, 'identificationModule': {'nctId': 'NCT00019656', 'briefTitle': 'Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer', 'nctIdAliases': ['NCT00001799'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms', 'orgStudyIdInfo': {'id': 'CDR0000066960'}, 'secondaryIdInfos': [{'id': 'NCI-99-C-0043'}, {'id': 'NCI-T98-0065'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'perifosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'NCI - Center for Cancer Research', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Edward A. Sausville, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}