Nctid:
NCT00002506
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D002583", "term"=>"Uterine Cervical Neoplasms"}, {"id"=>"D004938", "term"=>"Esophageal Neoplasms"}, {"id"=>"D012878", "term"=>"Skin Neoplasms"}, {"id"=>"D010412", "term"=>"Penile Neoplasms"}], "ancestors"=>[{"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D002577", "term"=>"Uterine Cervical Diseases"}, {"id"=>"D014591", "term"=>"Uterine Diseases"}, {"id"=>"D005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D004935", "term"=>"Esophageal Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D010409", "term"=>"Penile Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M5546", "name"=>"Carcinoma, Non-Small-Cell Lung", "relevance"=>"LOW"}, {"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5830", "name"=>"Uterine Cervical Neoplasms", "asFound"=>"Cervical Cancer", "relevance"=>"HIGH"}, {"id"=>"M8088", "name"=>"Esophageal Neoplasms", "asFound"=>"Esophageal Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5550", "name"=>"Carcinoma, Squamous Cell", "relevance"=>"LOW"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "relevance"=>"LOW"}, {"id"=>"M1730", "name"=>"Nasopharyngeal Carcinoma", "relevance"=>"LOW"}, {"id"=>"M1733", "name"=>"Esophageal Squamous Cell Carcinoma", "relevance"=>"LOW"}, {"id"=>"M15681", "name"=>"Skin Neoplasms", "asFound"=>"Skin Cancer", "relevance"=>"HIGH"}, {"id"=>"M10835", "name"=>"Laryngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M13323", "name"=>"Penile Neoplasms", "asFound"=>"Penile Cancer", "relevance"=>"HIGH"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5825", "name"=>"Uterine Cervical Diseases", "relevance"=>"LOW"}, {"id"=>"M17339", "name"=>"Uterine Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "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"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M13320", "name"=>"Penile Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"T2141", "name"=>"Esophageal Cancer", "asFound"=>"Esophageal Cancer", "relevance"=>"HIGH"}, {"id"=>"T4047", "name"=>"Nasopharyngeal Carcinoma", "relevance"=>"LOW"}, {"id"=>"T3311", "name"=>"Laryngeal Cancer", "relevance"=>"LOW"}, {"id"=>"T2952", "name"=>"Hypopharyngeal Cancer", "relevance"=>"LOW"}, {"id"=>"T4483", "name"=>"Penile Cancer", "asFound"=>"Penile Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007372", "term"=>"Interferons"}, {"id"=>"D016898", "term"=>"Interferon-alpha"}, {"id"=>"D015474", "term"=>"Isotretinoin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}], "browseLeaves"=>[{"id"=>"M16965", "name"=>"Tretinoin", "relevance"=>"LOW"}, {"id"=>"M18131", "name"=>"Isotretinoin", "asFound"=>"RBV", "relevance"=>"HIGH"}, {"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Phase II", "relevance"=>"HIGH"}, {"id"=>"M19243", "name"=>"Interferon-alpha", "asFound"=>"Parameters", "relevance"=>"HIGH"}, {"id"=>"M266317", "name"=>"Interferon-alfa-1b", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2011-05", "completionDateStruct"=>{"date"=>"1999-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2011-05-10", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-07-23", "lastUpdatePostDateStruct"=>{"date"=>"2011-05-12", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-26", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1996-01", "type"=>"ACTUAL"}}, "oversightModule"=>{"oversightHasDmc"=>false}, "conditionsModule"=>{"keywords"=>["recurrent non-small cell lung cancer", "recurrent esophageal cancer", "recurrent cervical cancer", "squamous cell lung cancer", "squamous cell carcinoma of the skin", "recurrent penile cancer", "recurrent skin cancer", "squamous cell carcinoma of the esophagus", "cervical squamous cell carcinoma", "penile squamous cell carcinoma", "recurrent squamous cell carcinoma of the lip and oral cavity", "recurrent squamous cell carcinoma of the oropharynx", "recurrent squamous cell carcinoma of the nasopharynx", "recurrent squamous cell carcinoma of the hypopharynx", "recurrent squamous cell carcinoma of the larynx", "recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity"], "conditions"=>["Cervical Cancer", "Esophageal Cancer", "Head and Neck Cancer", "Lung Cancer", "Non-melanomatous Skin Cancer", "Penile Cancer"]}, "referencesModule"=>{"references"=>[{"type"=>"RESULT", "citation"=>"Dillman RO, Soori G, Tai DF, et al.: Interferon alpha-2A (FN) and cis-retinoic acid (CRA) for the treatment of squamous cell carcinoma (SCC): a preliminary report. J Immunother 20(5): 404, 1997."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers.\n\nPURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer.", "detailedDescription"=>"OBJECTIVES: I. Determine the response rates to treatment with daily subcutaneous interferon alpha plus oral isotretinoin in patients with advanced squamous cell carcinomas of the following body sites: head and neck, cervix, skin, esophagus, lung, and penis. II. Determine the toxicities and side effects of this treatment.\n\nOUTLINE: Nonrandomized study. Single-agent Chemotherapy with Biological Response Modifier Therapy. Isotretinoin, 13-CRA, NSC-329481; with Interferon alpha (Schering or Hoffmann-La Roche), IFN-A, NSC-377523 or NSC-367982.\n\nPROJECTED ACCRUAL: 14-50 patients per tumor category (and any other tumor location, if available) will be enrolled. If none of the first 14 patients in any tumor category responds, or if only 1/22, 2/30, 3/37, 4/44, or 5/50 respond, the treatment will be considered ineffective for that tumor type."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma that has failed standard local modalities for local disease and/or effective systemic therapy for metastatic disease, or for which other forms of systemic therapy have been refused Eligible sites include but are not limited to: Uterine cervix Head and neck Skin Esophagus Lung Penis Measurable or evaluable disease required Measurable disease defined as previously unirradiated disease reproducibly measurable in 2 dimensions by physical exam, x-ray, CT, MRI, or other radiologic procedure Documented progressive disease in a previously irradiated site is accepted as measurable Evaluable disease includes: Any visible radiologic disease not measurable in 2 perpendicular diameters Elevated squamous cell carcinoma antigen (SCCA) No active brain metastases Previously treated brain metastases that have responded to therapy do not exclude, but CNS disease is not considered measurable or evaluable\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 30% Hepatic: Bilirubin less than 2.0 mg/dl PT normal PTT normal Renal: Creatinine less than 2.0 mg/dl Cardiovascular: No MI within 6 months No CHF requiring medication No arrhythmia requiring medication Pulmonary: Reasonable respiratory reserve required No requirement for supplemental oxygen No dyspnea at rest Other: No chronic underlying immunodeficiency disease No HIV positivity No pregnant patients (negative pregnancy test required) Adequate birth control required of fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concomitant immunosuppressive drugs, e.g., cyclosporin Chemotherapy: At least 3 weeks since prior systemic chemotherapy with recovery Endocrine therapy: No concomitant corticosteroids Radiotherapy: No prior radiotherapy to measurable site unless disease progression is documented Surgery: Not specified"}, "identificationModule"=>{"nctId"=>"NCT00002506", "briefTitle"=>"Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Hoag Memorial Hospital Presbyterian"}, "officialTitle"=>"ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS", "orgStudyIdInfo"=>{"id"=>"CDR0000077957"}, "secondaryIdInfos"=>[{"id"=>"CBRG-9208"}, {"id"=>"NBSG-9208"}, {"id"=>"NCI-V92-0159"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"recombinant interferon alfa", "type"=>"BIOLOGICAL"}, {"name"=>"isotretinoin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92658", "city"=>"Newport Beach", "state"=>"California", "country"=>"United States", "facility"=>"Hoag Memorial Hospital Presbyterian", "geoPoint"=>{"lat"=>33.61891, "lon"=>-117.92895}}, {"zip"=>"47402", "city"=>"Bloomington", "state"=>"Indiana", "country"=>"United States", "facility"=>"Bloomington Hospital", "geoPoint"=>{"lat"=>39.16533, "lon"=>-86.52639}}, {"zip"=>"46260", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"St. Vincent Hospital and Health Care Center", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"68124", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Bergan Mercy Medical Center", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"37901", "city"=>"Knoxville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Baptist Regional Cancer Center - Knoxville", "geoPoint"=>{"lat"=>35.96064, "lon"=>-83.92074}}, {"zip"=>"77802", "city"=>"Bryan", "state"=>"Texas", "country"=>"United States", "facility"=>"St. Joseph Regional Cancer Center", "geoPoint"=>{"lat"=>30.67436, "lon"=>-96.36996}}], "overallOfficials"=>[{"name"=>"Robert O. Dillman, MD, FACP", "role"=>"STUDY_CHAIR", "affiliation"=>"Cancer Biotherapy Research Group"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoag Memorial Hospital Presbyterian", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Cancer Biotherapy Research Group", "class"=>"OTHER"}], "responsibleParty"=>{"oldNameTitle"=>"Robert O. Dillman, MD", "oldOrganization"=>"Hoag Memorial Hospital Presbyterian"}}}}
