Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00022451
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2001-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tipifarnib in Treating Young Patients With Refractory Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D054429', 'term': 'Leukemia, Myelomonocytic, Juvenile'}], '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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C402769', 'term': 'tipifarnib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent childhood acute lymphoblastic leukemia', 'recurrent childhood acute myeloid leukemia', 'relapsing chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'chronic myelogenous leukemia, BCR-ABL1 positive', 'childhood acute promyelocytic leukemia (M3)', 'acute undifferentiated leukemia', 'juvenile myelomonocytic leukemia', 'childhood chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '16921263', 'type': 'BACKGROUND', 'citation': 'de Nigris F, Balestrieri ML, Napoli C. Targeting c-Myc, Ras and IGF cascade to treat cancer and vascular disorders. Cell Cycle. 2006 Aug;5(15):1621-8. doi: 10.4161/cc.5.15.3138. Epub 2006 Aug 1.'}, {'pmid': '20860038', 'type': 'RESULT', 'citation': "Widemann BC, Arceci RJ, Jayaprakash N, Fox E, Zannikos P, Goodspeed W, Goodwin A, Wright JJ, Blaney SM, Adamson PC, Balis FM. Phase 1 trial and pharmacokinetic study of the farnesyl transferase inhibitor tipifarnib in children and adolescents with refractory leukemias: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Feb;56(2):226-33. doi: 10.1002/pbc.22775. Epub 2010 Sep 21."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.\n\nPURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia.\n* Determine the pharmacokinetics of this drug in these patients.\n* Determine the toxicity profile of this drug in these patients.\n\nSecondary\n\n* Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug.\n* Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug in these patients.\n\nOUTLINE: This is an open-label, dose-escalation study.\n\nPatients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. At least 9 additional patients are treated at the MTD.\n\nPROJECTED ACCRUAL: A total of 12-34 patients will be accrued for this study within 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed acute lymphoblastic leukemia, acute nonlymphoblastic leukemia, juvenile myelomonocytic leukemia (JMML), or chronic myelogenous leukemia (CML) in blast crisis\n\n * Refractory to standard curative therapy\n * Acute promyelocytic leukemia refractory to tretinoin and arsenic trioxide\n * Philadelphia chromosome-positive CML refractory to imatinib mesylate\n* Greater than 25% blasts in bone marrow (M3 bone marrow) except for patients with JMML\n* Active extramedullary disease allowed\n* No active leptomeningeal leukemia\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and under\n\nPerformance status:\n\n* Karnofsky 50-100% (over 10 years of age)\n* Lansky 50-100% (10 years of age and under)\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not required to be normal\n\nHepatic:\n\n* Bilirubin normal\n* SGPT and SGOT normal\n* No significant hepatic dysfunction\n* No grade 3 or 4 liver function test results within the past month\n\nRenal:\n\n* Creatinine normal OR\n* Creatinine clearance at least 60 mL/min\n* No significant renal dysfunction\n\nCardiovascular:\n\n* No significant cardiac dysfunction\n\nPulmonary:\n\n* No significant pulmonary dysfunction\n\nNeurologic:\n\n* No history of grand mal seizures grade 3 or greater except febrile seizures\n* No persistent sensory or motor neuropathy greater than grade 2\n\nOther:\n\n* No clinically significant unrelated systemic illness\n* No serious infection\n* No organ dysfunction that would preclude study participation\n* No requirement for total parenteral nutrition\n* No known allergy to azoles (e.g., clotrimazole, fluconazole, ketoconazole, voriconazole)\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* At least 1 week since prior colony-stimulating factor therapy (e.g., filgrastim \\[G-CSF\\] or sargramostim \\[GM-CSF\\]) except epoetin alfa\n* At least 3 months since prior myeloablative therapy followed by bone marrow or stem cell transplantation\n* No concurrent immunotherapy\n* No concurrent GM-CSF or interleukin-11\n\nChemotherapy:\n\n* At least 2 weeks since prior chemotherapy\n* No concurrent intrathecal chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* At least 1 week since prior corticosteroids\n* No concurrent corticosteroids (except for acute allergic reaction)\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Recovered from nonhematologic toxicity of all prior therapy\n* At least 1 week since prior retinoids\n* No antacids (magnesium- or aluminum-containing formulations) within 2 hours of study drug\n* No other concurrent investigational agents\n* No concurrent retinoids\n* No concurrent anticonvulsants'}, 'identificationModule': {'nctId': 'NCT00022451', 'briefTitle': 'Tipifarnib in Treating Young Patients With Refractory Leukemia', 'nctIdAliases': ['NCT00017888'], 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia', 'orgStudyIdInfo': {'id': '010196'}, 'secondaryIdInfos': [{'id': '01-C-0196C'}, {'id': 'COG-ADVL0116'}, {'id': 'NCI-1930'}, {'id': 'CDR0000068819'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'tipifarnib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research 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Widemann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': "Children's Oncology Group", 'class': 'NETWORK'}]}}}