Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-27 @ 10:01 PM
Study NCT ID:
NCT00087295
Status:
TERMINATED
Last Update Posted:
2012-11-02
First Post:
2004-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014523', 'term': 'Urethral Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014522', 'term': 'Urethral Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047630', 'term': 'Depsipeptides'}, {'id': 'C087123', 'term': 'romidepsin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Permanently Closed Due to Poor Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2004-07-08', 'studyFirstSubmitQcDate': '2004-07-09', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probability of response (confirmed complete and partial)', 'timeFrame': 'From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years'}, {'measure': 'Overall survival', 'timeFrame': 'From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years'}, {'measure': 'Number and grade of adverse events', 'timeFrame': 'From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent bladder cancer', 'stage IV bladder cancer', 'transitional cell carcinoma of the bladder', 'metastatic transitional cell cancer of the renal pelvis and ureter', 'recurrent transitional cell cancer of the renal pelvis and ureter', 'anterior urethral cancer', 'posterior urethral cancer', 'recurrent urethral cancer', 'urethral cancer associated with invasive bladder cancer'], 'conditions': ['Bladder Cancer', 'Transitional Cell Cancer of the Renal Pelvis and Ureter', 'Urethral Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) .\n* Determine progression-free and overall survival of patients treated with this drug.\n* Determine the qualitative and quantitative toxic effects of this drug in these patients.\n* Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients.\n* Correlate, preliminarily, tumor DNA in plasma with response or outcome 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. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response receive 2 additional courses of treatment.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal pelvis, ureter, or urethra)\n\n * Metastatic disease\n\n * Node-positive, non-metastatic disease that is unresectable is allowed\n * Poorly differentiated transitional cell carcinoma OR predominant transitional cell carcinoma with rare foci of squamous differentiation or rare foci of adenocarcinoma allowed\n* The following histologic types are not allowed:\n\n * Adenocarcinoma\n * Small cell carcinoma\n * Sarcoma\n * Squamous cell carcinoma\n * Mixed adeno/squamous/transitional histology\n* Measurable disease\n\n * At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan\n * Soft tissue disease irradiated within the past 2 months is not considered measurable\n* Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy regimen that included cisplatin or carboplatin for metastatic disease\n* Not curable by surgery or radiotherapy\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Not specified\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* White blood cell (WBC) count ≥ 3,000/mm\\^3\n\nHepatic\n\n* Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper limit of normal (ULN)\n* Bilirubin normal\n\nRenal\n\n* Creatinine ≤ 2 times ULN\n\nCardiovascular\n\n* Corrected QT interval (QTc) \\< 500 msec\n* Left ventricular ejection fraction (LVEF) \\> 40% by Multi Gated Acquisition Scan (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 poorly controlled angina\n* No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)\n* No left ventricular hypertrophy on EKG\n* No other significant cardiac disease\n\nOther\n\n* Potassium ≥ 4 mmol/L\n* Magnesium ≥ 2 mg/dL\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 (depsipeptide)\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 28 days since prior chemotherapy\n* No prior FR901228 (depsipeptide)\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 28 days since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* More than 28 days since prior surgery\n\nOther\n\n* Recovered from all prior therapy\n* More than 28 days since prior intravesical therapy\n* No concurrent hydrochlorothiazide\n* No concurrent agent that causes QTc prolongation\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent investigational histone deacetylase inhibitor agents or drugs (e.g., sodium valproate)\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00087295', 'briefTitle': 'S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease', 'orgStudyIdInfo': {'id': 'CDR0000373886'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0400', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Depsipeptide', 'interventionNames': ['Drug: Depsipeptide']}], 'interventions': [{'name': 'Depsipeptide', 'type': 'DRUG', 'otherNames': ['FR901228', 'FK228'], 'description': 'Depsipeptide wil be given 13 mg/m\\^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel P. Petrylak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}