Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00002693
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D001752', 'term': 'Blast Crisis'}], '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': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'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': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-10', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent adult acute myeloid leukemia', 'recurrent adult acute lymphoblastic leukemia', 'relapsing chronic myelogenous leukemia', 'accelerated phase chronic myelogenous leukemia', 'blastic phase chronic myelogenous leukemia', 'neutropenia'], 'conditions': ['Leukemia', 'Neutropenia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kaufmann S, Letendre L, Litzow M, et al.: Phase I study of continuous infusion (CI) topotecan (TPT) and carboplatin (CBDCA) for relapsed or refractory acute leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A107, 1998.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Estimate the maximum tolerated dose of carboplatin plus topotecan given as a 5-day continuous infusion in patients with recurrent acute lymphocytic or myeloid leukemia or accelerated or blastic phase chronic myelogenous leukemia.\n* Assess the toxicity of this regimen in these patients.\n* Gather preliminary information on the activity of this regimen in these patients.\n* Examine the pharmacokinetics of topotecan when administered concurrently with carboplatin.\n\nOUTLINE: This is a dose escalation study of topotecan. Patients are stratified according to prior bone marrow transplant (BMT) (yes vs no).\n\n* Induction: Patients receive carboplatin and topotecan IV 3 times a day on days 1-5. Patients may also receive filgrastim (G-CSF) beginning on day 7 or 14. Retreatment is based on results of marrow exam on day 10-14. Patients with less than 5% blasts undergo a second marrow exam upon blood count recovery or on day 26-30, whichever is earlier. Patients with at least 5% blasts after day 21 receive one more course, in the absence of unacceptable toxicity and at the discretion of the investigator. Patients with no greater than 5% blasts begin G-CSF if blood counts are not recovered, then proceed to consolidation.\n\nCohorts of 1-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose limiting toxicity. Patients with prior BMT will not be entered at any level until 3-6 patients with no prior BMT tolerate that level.\n\n* Consolidation (begins around day 42 of last Induction course): Patients with ALL/AML in complete remission (CR) or CML in chronic phase receive 2 additional courses (same doses) 6-8 weeks apart.\n\nPatients experiencing a relapse after CR lasting at least 6 months may receive additional treatment.\n\nPROJECTED ACCRUAL: A total of 15-20 patients without and 2-20 patients with prior bone marrow transfer will be accrued for this study over 2-2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories:\n\n * Failed to achieve a complete response (CR) with initial induction regimen\n * First relapse within 1 year of initial CR\n * Failed re-induction therapy at first relapse\n * Second relapse after no more than 2 different induction regimens\n * Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either:\n\n * Symptoms of recurrence (e.g., B symptoms)\n * Evidence of impending marrow failure (i.e., cytopenias) OR\n* Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen\n* No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation\n* No clinical symptoms of CNS leukemia\n\n * Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease\n* No active CNS disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 4 weeks\n\nHematologic:\n\n* Not applicable\n\nHepatic:\n\n* Bilirubin less than 2 mg/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No congestive heart failure\n* No poorly controlled arrhythmia\n* No myocardial infarction within the past 3 months\n\nOther:\n\n* No active infection\n* No other serious medical condition that would prevent compliance\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 24 hours since prior hydroxyurea for impending leukostasis\n* No concurrent hydroxyurea glucocorticoids\n* Recovered from prior chemotherapy\n\nEndocrine therapy:\n\n* At least 24 hours since prior glucocorticoids for impending leukostasis\n* At least 7 days since prior amphotericin or aminoglycosides\n* No concurrent glucocorticoids\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent aminoglycoside antibiotics'}, 'identificationModule': {'nctId': 'NCT00002693', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'PHASE I STUDY OF CONTINUOUS INFUSION CARBOPLATIN AND TOPOTECAN IN THE TREATMENT OF RELAPSED ACUTE LEUKEMIA AND BLAST CRISIS CHRONIC MYELOGENOUS LEUKEMIA', 'orgStudyIdInfo': {'id': 'CDR0000064447'}, 'secondaryIdInfos': [{'id': 'U01CA069912', 'link': 'https://reporter.nih.gov/quickSearch/U01CA069912', 'type': 'NIH'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': '958101', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'topotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Scott H. Kaufmann, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Scott Harold Kaufmann, M.D. Ph.D.', 'oldOrganization': 'Mayo Clinic Cancer Center'}}}}