Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-27 @ 11:23 AM
Study NCT ID:
NCT00114257
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2005-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'C580364', 'term': 'Pdgfra-Associated Chronic Eosinophilic Leukemia'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D015467', 'term': 'Leukemia, Neutrophilic, Chronic'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'C087123', 'term': 'romidepsin'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2005-06-13', 'studyFirstSubmitQcDate': '2005-06-13', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity at 6 weeks after each course'}], 'secondaryOutcomes': [{'measure': 'Complete and partial response at 6 weeks after each course'}]}, 'conditionsModule': {'keywords': ['recurrent adult acute lymphoblastic leukemia', '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)', 'recurrent adult acute myeloid leukemia', 'secondary acute myeloid leukemia', 'untreated adult acute myeloid leukemia', 'adult acute promyelocytic leukemia (M3)', 'relapsing chronic myelogenous leukemia', 'refractory chronic lymphocytic leukemia', 'de novo myelodysplastic syndromes', 'myelodysplastic/myeloproliferative neoplasm, unclassifiable', 'previously treated myelodysplastic syndromes', 'secondary myelodysplastic syndromes', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'chronic myelomonocytic leukemia', 'chronic eosinophilic leukemia', 'primary myelofibrosis', 'chronic neutrophilic leukemia', 'essential thrombocythemia', 'polycythemia vera', 'Philadelphia chromosome negative chronic myelogenous leukemia', 'chronic myelogenous leukemia, BCR-ABL1 positive', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute basophilic leukemia', 'adult acute eosinophilic leukemia'], 'conditions': ['Chronic Myeloproliferative Disorders', 'Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms']}, 'descriptionModule': {'briefSummary': 'This phase I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with relapsed or refractory leukemia, myelodysplastic syndromes or myeloproliferative disorders. Drugs used in chemotherapy, such as decitabine and FR901228, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving decitabine together with FR901228 may kill more cancer cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the maximum tolerated dose and recommended phase II dose of decitabine and FR901228 (depsipeptide) in patients with relapsed or refractory leukemia, myelodysplastic syndromes, or myeloproliferative disease.\n\nII. Determine the safety and tolerability of this regimen in these patients.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the clinical activity of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 (depsipeptide) IV over 4 hours on days 5 and 12 OR days 5, 12, and 19. Treatment repeats every 4-6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing complete remission for 1 year are removed from the study.\n\nCohorts of 6 patients receive escalating doses of decitabine and FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of 1 of the following hematologic malignancies:\n\n * Acute myeloid leukemia\n\n * Previously untreated patients \\> 60 years of age who are not eligible for front-line therapy are eligible for this study\n * Acute lymphoblastic leukemia\n * Chronic myelogenous leukemia (CML)\n\n * Documented hematologic resistance to imatinib mesylate OR no cytogenetic response after 12 months of prior treatment with imatinib mesylate\n * Philadelphia chromosome-negative CML allowed provided disease is resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \\> 5% and platelet count \\< 100,000/mm\\^3) during standard therapy\n * Myelodysplastic syndromes\n\n * International Prognostic Scoring System risk category ≥ intermediate-1\n * Patients who are not eligible for front-line therapy are eligible for this study\n * Myeloproliferative disease\n * Chronic lymphocytic leukemia\n\n * Failed or progressed during ≥ 1 prior fludarabine-based therapy AND alemtuzmab\n * Acute promyelocytic leukemia\n\n * Progressed after prior treatment with standard chemotherapy, tretinoin, and arsenic trioxide\n * Chronic myelomonocytic leukemia\n\n * Resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \\> 5% and platelet count \\< 100,000/mm\\^3) during standard therapy\n* Relapsed or refractory disease\n* No known brain or meningeal disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* More than 8 weeks\n\nHepatic\n\n* Bilirubin \\< 2 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal\n\nRenal\n\n* Creatinine \\< 2 mg/dL\n\nCardiovascular\n\n* QTc \\< 500 msec\n* LVEF \\> 40% by MUGA\n* No New York Heart Association class III or IV congestive heart failure\n* No myocardial infarction within the past year\n* No uncontrolled dysrhythmias\n* No uncontrolled angina\n* No left ventricular hypertrophy by EKG\n* No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)\n* No other significant cardiac disease\n\nImmunologic\n\n* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs\n* No ongoing or active infection\n* No HIV positivity\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No psychiatric illness or social situation that would preclude study compliance\n* No other uncontrolled illness\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* Recovered from prior chemotherapy\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) unless there is evidence of rapidly progressive disease\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy and recovered\n\nOther\n\n* No concurrent agents that cause QTc prolongation\n* No other concurrent investigational or commercial agents or therapies for the malignancy\n* No concurrent hydrochlorothiazide\n\n * Concurrent potassium-conserving combinations (e.g., Maxide® or Dyazide®) or other antihypertensive agents allowed'}, 'identificationModule': {'nctId': 'NCT00114257', 'briefTitle': 'Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "A Phase I Study of 5-AZA-2'-Deoxycytidine and Depsipeptide in Patients With Relapsed/Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disease", 'orgStudyIdInfo': {'id': 'NCI-2012-02657'}, 'secondaryIdInfos': [{'id': 'MDA-2004-0674'}, {'id': 'NCI-5563'}, {'id': 'CDR0000433040', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 and FR901228 (depsipeptide) IV over 4 hours on days 5 and 12 OR days 5, 12, and 19. Treatment repeats every 4-6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing complete remission for 1 year are removed from the study.\n\nCohorts of 6 patients receive escalating doses of decitabine and FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.', 'interventionNames': ['Drug: decitabine', 'Drug: romidepsin']}], 'interventions': [{'name': 'decitabine', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}, {'name': 'romidepsin', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jean-Pierre Issa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}