Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT00301769
Status:
TERMINATED
Last Update Posted:
2013-09-30
First Post:
2006-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': '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': 'D015448', 'term': 'Leukemia, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C423343', 'term': "1,1'-((propane-1,3-diyl)dioxy)bis(7-methoxy-2-methylidene-1,2,3,10,11,11a-hexahydro-5H-pyrrolo(2,1-c)(1,4)benzodiazepin-5,11-dione)"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2006-03-09', 'studyFirstSubmitQcDate': '2006-03-09', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)', 'timeFrame': '21 days'}]}, 'conditionsModule': {'conditions': ['Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Blastic Phase Chronic Myelogenous Leukemia', 'de Novo Myelodysplastic Syndromes', 'Previously Treated Myelodysplastic Syndromes', 'Recurrent Adult Acute Lymphoblastic Leukemia', 'Recurrent Adult Acute Myeloid Leukemia', 'Refractory Chronic Lymphocytic Leukemia', 'Relapsing Chronic Myelogenous Leukemia', 'Secondary Acute Myeloid Leukemia', 'Secondary Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.', 'detailedDescription': 'OBJECTIVES:\n\nI. Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome (MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic leukemia (CLL).\n\nII. Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.\n\nCohorts of 3-6 patients receive escalating doses of SJG-136 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. A total of 10 patients are treated at the MTD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of 1 of the following hematologic malignancies:\n\n * Acute myeloid leukemia\n * Acute lymphoblastic leukemia\n * Myelodysplastic syndromes\n * Chronic myelogenous leukemia in blastic phase\n * Chronic lymphocytic leukemia\n* Relapsed or refractory disease\n* No immediately available, potentially curable options (e.g., stem cell transplantation) available\n* Bilirubin normal (unless elevated due to Gilbert's syndrome)\n* HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No uncontrolled intercurrent illness including, but not limited to, any of the following:\n\n * Ongoing or active infection\n * Symptomatic congestive heart failure\n * Unstable angina pectoris\n * Cardiac arrhythmia\n * Psychiatric illness or social situations that would limit study compliance\n* Recovered from prior therapy\n* ECOG performance status =\\< 2\n* SGOT and SGPT =\\< 2.5 times upper limit of normal (ULN)\n* Creatinine normal OR creatinine clearance \\>= 60 mL/min\n* Primary resistance (i.e., failed to achieve a complete remission \\[CR\\] to a standard induction regimen) or relapsed after achievement of a CR.\n* Must have documented failure to last cytotoxic regimen prior to study entry.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* No known CNS disease\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136\n* More than 7 days since radiotherapy\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other anti-leukemia agents except hydroxyurea =\\< 5 grams/day =\\< 14 days prior to and during first course of treatment to control blood counts"}, 'identificationModule': {'nctId': 'NCT00301769', 'briefTitle': 'SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study of SJG-136 in Patients With Advanced Leukemia', 'orgStudyIdInfo': {'id': 'NCI-2009-00100'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00100', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000462379'}, {'id': '2005-0607', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': '6934', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U01CA062461', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062461', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of SJG-136 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. A total of 10 patients are treated at the MTD.', 'interventionNames': ['Drug: SJG-136']}], 'interventions': [{'name': 'SJG-136', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Farhad Ravandi-Kashani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}