Nctid:
NCT00001444
Payload:
{"FullStudy"=>{"Rank"=>497942, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009369", "ConditionMeshTerm"=>"Neoplasms"}, {"ConditionMeshId"=>"D000011471", "ConditionMeshTerm"=>"Prostatic Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000005834", "ConditionAncestorTerm"=>"Genital Neoplasms, Male"}, {"ConditionAncestorId"=>"D000014565", "ConditionAncestorTerm"=>"Urogenital Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000005832", "ConditionAncestorTerm"=>"Genital Diseases, Male"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000011469", "ConditionAncestorTerm"=>"Prostatic Diseases"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11220", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5220", "ConditionBrowseLeafName"=>"Breast Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14335", "ConditionBrowseLeafName"=>"Prostatic Neoplasms", "ConditionBrowseLeafAsFound"=>"Prostatic Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M8946", "ConditionBrowseLeafName"=>"Genital Neoplasms, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17315", "ConditionBrowseLeafName"=>"Urogenital Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8944", "ConditionBrowseLeafName"=>"Genital Diseases, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2875", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14333", "ConditionBrowseLeafName"=>"Prostatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27095", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"C000054852", "InterventionMeshTerm"=>"7-hydroxystaurosporine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000047428", "InterventionAncestorTerm"=>"Protein Kinase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M349301", "InterventionBrowseLeafName"=>"7-hydroxystaurosporine", "InterventionBrowseLeafAsFound"=>"Hippotherapy", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M25820", "InterventionBrowseLeafName"=>"Protein Kinase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"51"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1995"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2002", "CompletionDateStruct"=>{"CompletionDate"=>"May 2002"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Pharmacokinetics", "Natural Products", "Salvage Therapy", "Protein Kinase Antagonist"]}, "ConditionList"=>{"Condition"=>["Breast Cancer", "Lymphoma", "Neoplasm", "Prostatic Neoplasm"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8022414", "ReferenceType"=>"background", "ReferenceCitation"=>"Seynaeve CM, Kazanietz MG, Blumberg PM, Sausville EA, Worland PJ. Differential inhibition of protein kinase C isozymes by UCN-01, a staurosporine analogue. Mol Pharmacol. 1994 Jun;45(6):1207-14."}, {"ReferencePMID"=>"7683251", "ReferenceType"=>"background", "ReferenceCitation"=>"Seynaeve CM, Stetler-Stevenson M, Sebers S, Kaur G, Sausville EA, Worland PJ. Cell cycle arrest and growth inhibition by the protein kinase antagonist UCN-01 in human breast carcinoma cells. Cancer Res. 1993 May 1;53(9):2081-6."}, {"ReferencePMID"=>"1893379", "ReferenceType"=>"background", "ReferenceCitation"=>"Akinaga S, Gomi K, Morimoto M, Tamaoki T, Okabe M. Antitumor activity of UCN-01, a selective inhibitor of protein kinase C, in murine and human tumor models. Cancer Res. 1991 Sep 15;51(18):4888-92."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient benefits.", "DetailedDescription"=>"Patients with relapsed or refractory neoplasms will be treated with escalating doses of UCN-01(7-hydroxystaurosporine) a protein kinase C inhibitor which also may affect cyclin-dependent kinase activity, given as a 72 hour infusion. This trial will determine the toxicity associated with the maximally tolerated dose of this drug in patients for whom no other therapeutic approach is deemed to be more useful."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patients must have a histologic diagnosis of a solid tumor or lymphoma confirmed by the Laboratory of Pathology, NCI and have failed standard chemotherapy.\n\nNo patients with leukemia, brain metastasis, or primary brain tumors.\n\nPatients must be older than 18 years of age .\n\nMust have a SGPT and SGOT less than 2.5 times the upper normal limits.\n\nLiver tumor replacement should be less than 50% total liver surface.\n\nTotal bilirubin must be less than 1.5 times the upper limit and measured creatinine clearance of at least 55 ml/min.\n\nHemoglobin must be greater than 9.0.\n\nPlatelet count must be greater than 100,000, and absolute granulocyte count greater than 1,500.\n\nPT/PTT must be within normal range.\n\nMust have a performance status ECOG of 0-2.\n\nMust have the ability to give informed consent.\n\nMust have reliability to return for follow up and treatment, and to follow instructions.\n\nThe patient must not have received radiation therapy of chemotherapy within the past 4 weeks and have recovered from all toxicities prior to starting therapy.\n\nPatients must not have received any nitrosureas, mitomycin C, or bone seeking radioisotopes within 6 weeks of entry.\n\nPatients with prostate cancer:\n\nMust have had tumor progression following blockade of both testicular and adrenal androgens.\n\nIf taking flutamide or any other anti-androgen, this will have to be discontinued at least four weeks prior to treatment with evidence of progression of disease following this maneuver.\n\nLeuprolide or any other GnRh analog should be maintained if the patient has not had an orchiectomy.\n\nAll prostate cancer patients must have a serum testosterone in the castrate range.\n\nExposure to suramin:\n\nPatients with prior exposure to suramin should be at least 3 months off therapy (from the last day of infusion) and have undetectable suramin levels.\n\nPatients with breast carcinoma who are taking a hormonal treatment should discontinue this medication for at least 4 weeks prior to treatment with UCN-01 and have showed further progression of disease after this maneuver.\n\nPatients may not be treated if any of the following is present:\n\nActive infection, requiring antibiotics within 7 days prior to entry.\n\nBacterial colonization secondary to percutaneous nephrostomy tube, ileal pouch, or indwelling urinary catheter.\n\nPositive serology for HIV.\n\nGreater than grade I peripheral neuropathy at study entry.\n\nPrior radiation therapy to greater than or equal to 30% of their bone marrow.\n\nNo patients with local complications which require urgent local therapy (e.g.: untreated hydronephrosis, impending spinal cord compression, severe bone pain unresponsive to analgesics).\n\nNo patients with a history of unstable or newly diagnoses angina pectoris, recent myocardial infarction (within 6 months of enrollment), class II-IV congestive heart failure, severe chronic obstructive lung disease (forced vital capacity less than 1000 ml).\n\nNo patients with uncontrolled seizure activity, controlled seizure activity but with less than one year free of seizures.\n\nPatients with a past history of seizures must be seizure free for greater than a year and not taking any anticonvulsant medications.\n\nNo patients with coagulopathy or active renal disease.\n\nNo patients receiving steroids for other than physiologic replacement.\n\nEffective June 10, 1998, patients with history of diabetes mellitus within 6 months of enrollment or fasting glucose greater than or equal to 116/mg/dl or Hemoglobin A1C greater than 6.5 mg/dl will not be eligible.\n\nIf the patient is a premenopausal female she must have a negative pregnancy test (b-HCG) and be counseled concerning the necessity for effective contraception\n\nNo lactating females.\n\nBoth male and female patients must practice effective contraception while on study and for four months following its conclusion."}, "IdentificationModule"=>{"NCTId"=>"NCT00001444", "BriefTitle"=>"A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950171"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-C-0171"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"7-hydroxystaurosporine (UCN-01)", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}
