Nctid:
NCT00001570
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D007680", "term"=>"Kidney Neoplasms"}], "ancestors"=>[{"id"=>"D009385", "term"=>"Neoplastic Processes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M10703", "name"=>"Kidney Neoplasms", "asFound"=>"Kidney Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M5548", "name"=>"Carcinoma, Renal Cell", "relevance"=>"LOW"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Neoplasm Metastasis", "relevance"=>"HIGH"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"T4906", "name"=>"Renal Cell Carcinoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D014747", "term"=>"Vinblastine"}], "ancestors"=>[{"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M17492", "name"=>"Vinblastine", "asFound"=>"Suction", "relevance"=>"HIGH"}, {"id"=>"M340819", "name"=>"polysaccharide-K", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>46}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-01", "completionDateStruct"=>{"date"=>"2001-01"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Cytochrome P 450", "Multi-Drug Resistance", "P-Glycoprotein", "Pharmacokinetics"], "conditions"=>["Kidney Neoplasms", "Neoplasm Metastasis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7855615", "type"=>"BACKGROUND", "citation"=>"Chapman AE, Goldstein LJ. Multiple drug resistance: biologic basis and clinical significance in renal-cell carcinoma. Semin Oncol. 1995 Feb;22(1):17-28. No abstract available."}, {"pmid"=>"8636778", "type"=>"BACKGROUND", "citation"=>"Boote DJ, Dennis IF, Twentyman PR, Osborne RJ, Laburte C, Hensel S, Smyth JF, Brampton MH, Bleehen NM. Phase I study of etoposide with SDZ PSC 833 as a modulator of multidrug resistance in patients with cancer. J Clin Oncol. 1996 Feb;14(2):610-8. doi: 10.1200/JCO.1996.14.2.610."}, {"pmid"=>"1359150", "type"=>"BACKGROUND", "citation"=>"Twentyman PR. MDR1 (P-glycoprotein) gene expression--implications for resistance modifier trials. J Natl Cancer Inst. 1992 Oct 7;84(19):1458-60. doi: 10.1093/jnci/84.19.1458. No abstract available."}]}, "descriptionModule"=>{"briefSummary"=>"Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, before the first cohort is enrolled.\n\nVinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered at each dose level. The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity.\n\nTreatment continues every 28 days.", "detailedDescription"=>"The Phase I clinical trial of the combination of 120-hour continuous intravenous infusion of vinblastine with oral PSC 833 has shown activity in patients with advanced malignancies, particularly renal cell cancer. The MTD of vinblastine in combination with the oral drink solution of PSC 833 was determined to be 0.9 mg/m2/day for five days and 12.5 mg/kg po q 12 hours for eight days, respectively. For the soft gel capsule formulation, the MTD was determined to be 0.6 mg/m2/day vinblastine for five days and 4 mg/kg po q 6 hours PSC 833 for eight days. Ataxia was the dose limiting toxicity. Of the 46 patients, two complete remissions and one partial remission were seen among 29 patients with renal cell carcinoma.\n\nIn this Phase I study, patients with advanced renal carcinoma will be treated with escalating doses of vinblastine given as a 72 hour infusion, starting at approximately 40% of the total standard dose. A shorter infusion schedule of vinblastine was chosen since there is evidence in other cytotoxic combinations that PSC 833 increases the AUC and decreases the plasma clearance of chemotherapeutic agents by approximately twofold. Cytochrome P 450 3A or CYP3A, which is the major cytochrome enzyme in the metabolism of vinblastine and PSC 833, will be measured during the first and fourth cycle through an in vivo test using a single intravenous dose of midazolam, a short-acting benzodiazepine. Vinblastine and PSC 833 pharmacokinetics will be performed at the same time. For patients with accessible lesions, tumor biopsy will be requested."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically proven renal cancer with clear cell component:\n\nMeasurable or evaluable disease;\n\nNo brain metastases;\n\nNo grade 2 or greater peripheral neuropathy or neurologic toxicity symptoms.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Not specified.\n\nChemotherapy: No prior or concurrent hypersensitivity to PSC 833 or cyclosporine A.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: No prior radiation therapy within 4 weeks of study.\n\nSurgery: No major surgery within 4 weeks of study.\n\nOther: No concurrent treatments that interfere with cyclosporine blood concentrations.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance Status: ECOG 0-2.\n\nLife Expectancy: At least 16 weeks.\n\nHematopoietic:\n\nANC greater than or equal to 1500/mm(3);\n\nPlatelet count greater than or equal to 100,000/mm(3).\n\nHepatic:\n\nBilirubin no greater than 1.5 x normal;\n\nAST no greater than 2.5 x normal.\n\nRenal:\n\nCreatinine no greater than 2.0 mg/dL OR;\n\nCreatinine clearance greater than or equal to 50 mL/min.\n\nCardiovascular:\n\nNo concurrent angina or myocardial infarction that has not been appropriately treated.\n\nOther:\n\nNot pregnant or nursing.\n\nEffective contraceptive required of all fertile patients.\n\nPatients with a history of curatively treated basal cell or squamous cell carcinoma are eligible.\n\nNo HIV seropositivity.\n\nNo chronic hepatitis or cirrhosis.\n\nPatients with concurrent reversible conditions such as diabetes, hypercalcemia, hyperuricemia, hyperviscosity, infection, renal disease, or spinal cord compression are eligible with appropriate therapy.\n\nPatients must give written informed consent."}, "identificationModule"=>{"nctId"=>"NCT00001570", "briefTitle"=>"A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer", "orgStudyIdInfo"=>{"id"=>"970074"}, "secondaryIdInfos"=>[{"id"=>"97-C-0074"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"PSC 833", "type"=>"DRUG"}, {"name"=>"vinblastine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}