Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 2:00 PM
Study NCT ID:
NCT00085150
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], '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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077707', 'term': 'B3(Fv)-PE38KDEL recombinant immunotoxin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2004-06-10', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent adult T-cell leukemia/lymphoma', 'recurrent childhood acute lymphoblastic leukemia', 'childhood Burkitt lymphoma', 'recurrent childhood acute myeloid leukemia', 'recurrent childhood large cell lymphoma', 'recurrent childhood lymphoblastic lymphoma', 'recurrent mycosis fungoides/Sezary syndrome', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'recurrent/refractory childhood Hodgkin lymphoma', 'relapsing chronic myelogenous leukemia', 'acute undifferentiated leukemia'], 'conditions': ['Leukemia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma.\n* Determine the toxic effects of this drug in these patients.\n* Determine the pharmacokinetics of this drug, including the terminal elimination serum half-life, area under the curve, volume of distribution, and relationship to disease burden, in these patients.\n\nSecondary\n\n* Evaluate the immonogenicity of this drug in these patients.\n* Determine response in patients treated with this drug.\n* Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation, multicenter study.\n\nPatients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, neutralizing antibodies (i.e., \\> 75% of the activity of 1 µg/mL of LMB-2 immunotoxin), or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR. Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures.\n\nCohorts of 3-6 patients receive escalating doses of LMB-2 immunotoxin 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. Once the MTD is determined, a total of 12 patients are treated at that dose level.\n\nPatients are followed weekly for 1 month and then monthly thereafter.\n\nPROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 2-4 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 * Non-Hodgkin's lymphoma, including the following subtypes:\n\n * Lymphoblastic lymphoma\n * Burkitt's lymphoma\n * Large cell lymphoma\n * Adult T-cell leukemia/lymphoma\n * Cutaneous T-cell lymphoma\n * Peripheral T-cell lymphoma\n * Hodgkin's disease\n * Acute myeloid leukemia\n * Chronic myelogenous leukemia\n * Acute lymphoblastic leukemia (ALL)\n\n * More than 5% blasts in the bone marrow (i.e., M2 marrow classification)\n * Acute hybrid leukemia, including the following subtypes:\n\n * Mixed lineage leukemia\n * Biphenotypic leukemia\n * Undifferentiated leukemia\n* CD25-positive (CD25+) disease, meeting 1 of the following criteria:\n\n * More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody\n * More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis\n* Measurable or evaluable disease\n* Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen\n* No available alternative curative therapies\n* Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor\n* No CNS leukemia or lymphoma, as evidenced by any of the following criteria:\n\n * Cerebrospinal fluid (CSF) WBC \\> 5/µl AND confirmation of CSF blasts\n * Cranial neuropathies secondary to underlying malignancy\n * CNS lymphoma detected by radiological imaging\n\n * Prior CNS involvement with no current evidence of CNS malignancy allowed\n* No isolated testicular ALL\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 6 months to 21 years\n\nPerformance status\n\n* ECOG 0-3 (≥ 12 years of age)\n* Lansky 40-100% (\\< 12 years of age)\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Pancytopenia due to disease allowed\n* For patients without bone marrow involvement:\n\n * Absolute neutrophil count \\> 1,000/mm\\^3\n * Platelet count \\> 50,000/mm\\^3 (transfusion independent)\n\nHepatic\n\n* Bilirubin ≤ 2.0 mg/dL\n* AST and ALT ≤ 5 times upper limit of normal\n* Hepatitis B surface antigen negative\n* Hepatitis C antibody negative\n\nRenal\n\n* Creatinine clearance ≥ 60 mL/min OR\n* Creatinine, meeting the following age-related criteria:\n\n * ≤ 0.8 mg/dL (≤ 5 years of age)\n * ≤ 1.0 mg/dL (6 to 10 years of age)\n * ≤ 1.2 mg/dL (11 to 15 years of age)\n * ≤ 1.5 mg/dL (\\> 15 years of age)\n* Calcium 2.0-2.9 mmol/L\n\nCardiovascular\n\n* Ejection fraction ≥ 45% by MUGA OR\n* Shortening fraction ≥ 28% by echocardiogram\n\nPulmonary\n\n* Oxygen saturation ≥ 90%\n\nOther\n\n* Sodium 130-150 mmol/L\n* Potassium 3.0-5.5 mmol/L\n* Magnesium 0.5-1.23 mmol/L\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No clinically significant unrelated systemic illness that would preclude study participation\n* No conditions that would preclude study compliance\n* No serum that neutralizes \\> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies)\n* No active graft-vs-host disease (i.e., off immunosuppression)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior autologous bone marrow transplantation (BMT) allowed\n* At least 100 days since prior allogeneic BMT\n* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \\[G-CSF\\], sargramostim \\[GM-CSF\\], or epoetin alfa)\n\nChemotherapy\n\n* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment\n\n * Tapering or discontinuation of steroids allowed\n\nRadiotherapy\n\n* At least 3 weeks since prior radiotherapy unless \\< 10% of marrow is irradiated and measurable disease exists outside the radiation port\n\nSurgery\n\n* Not specified\n\nOther\n\n* Recovered from all prior therapy\n* At least 30 days since prior investigational agents\n* Concurrent oral supplementation to maintain normal electrolyte levels allowed\n* No concurrent anticoagulation therapy for disease-related conditions\n* No other concurrent investigational agents"}, 'identificationModule': {'nctId': 'NCT00085150', 'briefTitle': 'LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma', 'nctIdAliases': ['NCT00082004'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas', 'orgStudyIdInfo': {'id': 'CDR0000367333'}, 'secondaryIdInfos': [{'id': 'NCI-04-C-0168'}, {'id': 'NCI-5903'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'LMB-2 immunotoxin', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Doernbecher Children's Hospital at Oregon Health & Science University", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Alan S. Wayne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}