Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00077194
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2004-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C087123', 'term': 'romidepsin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-02', 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-10', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent adult diffuse large cell lymphoma', 'recurrent mantle cell lymphoma', 'recurrent adult Burkitt lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.", 'detailedDescription': "OBJECTIVES:\n\nI. Determine the response rate (complete and partial) in patients with relapsed or refractory Burkitt's, mantle cell or diffuse large cell non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).\n\nII. Determine the safety and feasibility of this drug, in terms of incidence and maximum grade of toxicity and courses delayed or doses reduced, in these patients.\n\nIII. Determine the 2-year progression-free survival and overall survival of patients treated with this drug.\n\nIV. Correlate tumor expression of BCL-2, BCL-6, BAX, and RAS with response in patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types:\n\n * Diffuse large cell\n * Mantle cell\n * Burkitt's\n* Relapsed or refractory disease\n\n * No more than 2 prior regimen for patients with refractory disease\n * Any number of prior therapies (including peripheral blood stem cell or bone marrow transplantation) allowed for patients with relapsed disease provided there was an objective response to the most recent therapy\n* Measurable disease\n\n * At least 1 lesion ≥ 1.5 cm in diameter\n* No transformed lymphoma\n* No CNS lymphoma\n* Ineligible for, refused, or relapsed after stem cell transplantation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,000/mm\\^3 (500/mm\\^3 in patients with extensive bone marrow involvement \\[\\> 50%\\] or hypersplenism with palpable splenomegaly)\n* Platelet count ≥ 75,000/mm\\^3 (50,000/mm\\^3 in patients with extensive bone marrow involvement or hypersplenism with palpable splenomegaly)\n\nHepatic\n\n* Bilirubin ≤ upper limit of normal (ULN)\n* Alkaline phosphatase ≤ 2 times ULN\n* AST ≤ 2 times ULN\n\nRenal\n\n* Creatinine ≤ ULN\n\nCardiovascular\n\n* QTc \\< 500 msec by ECG\n* Cardiac function ≥ 50% by MUGA\n* No prior serious ventricular arrhythmia\n* No New York Heart Association class III or IV congestive heart failure\n* No significant cardiac hypertrophy by ECG\n* No other significant cardiac disease\n\nPulmonary\n\n* No chronic obstructive pulmonary disease\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No active infection\n* No diabetes\n* No other uncontrolled serious medical condition\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* Prior cumulative doxorubicin dose \\< 450 mg/m\\^2\n* Prior cumulative mitoxantrone dose \\< 112 mg/m\\^2\n* Prior doxorubicin equivalent dose \\< 450 mg/m\\^2 (for patients who have previously received both doxorubicin and mitoxantrone)\n\nOther\n\n* Recovered from all prior therapy\n* No prior histone deacetylase inhibitor therapy\n* No concurrent medication associated with QTc prolongation, such as dolasetron\n* Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is on concurrent potassium chloride supplementation"}, 'identificationModule': {'nctId': 'NCT00077194', 'briefTitle': "FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': "A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'NCI-2012-02571'}, 'secondaryIdInfos': [{'id': 'MAYO-MC0287'}, {'id': 'NCI-5961'}, {'id': 'CDR0000349660', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: romidepsin']}], 'interventions': [{'name': 'romidepsin', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Cancer Center at Howard University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '53792-5256', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Nancy L. Bartlett, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University Siteman Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}