Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT00068302
Status:
TERMINATED
Last Update Posted:
2015-03-12
First Post:
2003-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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': '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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Recruiting/enrolling participants halted prematurely but potentially will resume', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-11', 'studyFirstSubmitDate': '2003-09-10', 'studyFirstSubmitQcDate': '2003-09-10', 'lastUpdatePostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity as assessed by Common Toxicity Criteria (CTC) toxicity criteria after the first course of treatment', 'timeFrame': 'within 21 days following administration of sirolimus', 'description': 'Subjects will be assessed for toxicity on days 3, 7 and 21'}], 'secondaryOutcomes': [{'measure': 'Response as assessed by radiologic scans after each course of treatment', 'timeFrame': 'day 21', 'description': 'Response will be assessed on day 21 of cycle 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent childhood lymphoblastic lymphoma', 'recurrent childhood small noncleaved cell lymphoma', 'recurrent childhood large cell lymphoma', 'recurrent childhood acute myeloid leukemia', 'recurrent childhood acute lymphoblastic leukemia'], 'conditions': ['Leukemia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy such as sirolimus use different ways to stop cancer cells from dividing so they stop growing or die.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in treating young patients with relapsed or refractory acute leukemia or non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkin's lymphoma.\n* Determine the dose-limiting toxic effects of this drug in these patients.\n* Determine the trough levels produced by this drug in these patients.\n* Determine the anti-leukemia/lymphoma activity of this drug in these patients.\n\nOUTLINE: This is an open-label, dose-escalation study.\n\nPatients receive oral sirolimus once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) 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.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of 1 of the following:\n\n * Acute lymphoblastic leukemia (ALL) OR acute myeloid leukemia (AML)\n\n * At least 25% blasts in the bone marrow\n * Recurrent or refractory disease\n * Non-Hodgkin's lymphoma (NHL)\n\n * Second or greater relapse as determined by physical or radiological evidence\n* Disease for which there is no known curative therapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 21 and under\n\nPerformance status\n\n* Karnofsky 50-100% (patients over 10 years of age)\n* Lansky 50-100% (patients 10 years of age and under)\n\nLife expectancy\n\n* At least 4 weeks\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,000/mm\\^3\\*\n* Platelet count at least 75,000/mm\\^3 (transfusion independent)\\*\n* Hemoglobin at least 8.0 g/dL (may receive red blood cells (RBC) transfusions)\\* NOTE: \\*Patients with ALL, AML, and NHL with tumor metastatic to bone marrow, with granulocytopenia, anemia, and/or thrombocytopenia are eligible, but will not be evaluable for hematological toxicity\n\nHepatic\n\n* Bilirubin no greater than 1.5 times normal\n* alanine aminotransferase (ALT) no greater than 5 times normal\n* Albumin at least 2 g/dL\n\nRenal\n\n* Creatinine based on age, as follows:\n\n * No greater than 0.8 mg/dL (5 years of age and under)\n * No greater than 1.0 mg/dL (6 to 10 years of age)\n * No greater than 1.2 mg/dL (11 to 15 years of age)\n * No greater than 1.5 mg/dL (over 15 years of age) OR\n* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\n\nCardiovascular\n\n* Shortening fraction at least 28% by echocardiogram OR\n* Ejection fraction at least 50% by gated radionuclide\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to ingest oral medication\n* No known allergy to sirolimus, tacrolimus, or other mammalian target of rapamycin (mTOR) inhibitors\n* No uncontrolled active infection\n\n * Fungal disease must be stable for at least 2 weeks prior to study entry\n * Documented negative blood cultures prior to study entry for patients with bacteremia\n* No active graft-versus-host disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Recovered from prior immunotherapy\n* More than 1 week since prior hematopoietic growth factors except for epoetin alfa\n* At least 7 days since prior biologic antineoplastic agents\n* At least 3 months since prior bone marrow or stem cell transplantation\n\nChemotherapy\n\n* Recovered from all prior chemotherapy\n* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)\n* Prior hydroxyurea within the past 2 weeks is allowed provided peripheral blast count has been stable or rising for at least 3 days\n\nEndocrine therapy\n\n* Prior corticosteroids within the past 2 weeks are allowed provided peripheral blast count has been stable or rising for at least 3 days\n\nRadiotherapy\n\n* Recovered from prior radiotherapy\n* At least 2 weeks since prior local palliative radiotherapy\n* At least 4 weeks since prior craniospinal radiotherapy or radiation to the pelvis of 50% or more\n* At least 4 weeks since prior substantial bone marrow radiotherapy\n* No concurrent radiotherapy, except for emergent situations or persistent extramedullary disease with resolution of bone marrow disease\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent investigational antineoplastic drugs\n* No concurrent administration of any of the following:\n\n * Ketoconazole\n * Tacrolimus\n * Cyclosporine\n * Rifampin\n * Diltiazem"}, 'identificationModule': {'nctId': 'NCT00068302', 'briefTitle': "Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': "A Phase I Trial Of Sirolimus In Relapsed/Refractory Leukemia And Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CDR0000321392'}, 'secondaryIdInfos': [{'id': 'CHP-755'}, {'id': 'CHP-IRB-2002-12-3086'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirolimus', 'description': 'This is a dose escalation study including 4-dose levels. Subjects will receive a one-time loading dose of sirolimus on day 0, time 0. Subsequent dosing at the assigned dose level will start 24 hours following the initial loading dose', 'interventionNames': ['Drug: sirolimus']}], 'interventions': [{'name': 'sirolimus', 'type': 'DRUG', 'otherNames': ['rapamycin', 'Rapamune'], 'description': '3-6 subjects will be enrolled into each dose level', 'armGroupLabels': ['Sirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Susan Rheingold, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Childhood Cancer Foundation', 'class': 'UNKNOWN'}, {'name': 'The Leukemia and Lymphoma Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}