Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT00066404
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2003-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D014523', 'term': 'Urethral Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010412', 'term': 'Penile Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D013945', 'term': 'Thymoma'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital 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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2003-08-06', 'studyFirstSubmitQcDate': '2003-08-06', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['advanced malignant mesothelioma', 'male breast cancer', 'localized malignant mesothelioma', 'recurrent bladder cancer', 'recurrent renal cell cancer', 'recurrent urethral cancer', 'recurrent breast cancer', 'recurrent penile cancer', 'recurrent prostate cancer', 'recurrent anal cancer', 'recurrent colon cancer', 'recurrent esophageal cancer', 'recurrent gastric cancer', 'recurrent pancreatic cancer', 'recurrent rectal cancer', 'recurrent gastrointestinal carcinoid tumor', 'recurrent small intestine cancer', 'recurrent gallbladder cancer', 'recurrent extrahepatic bile duct cancer', 'recurrent adult primary liver cancer', 'recurrent non-small cell lung cancer', 'recurrent small cell lung cancer', 'recurrent thymoma and thymic carcinoma', 'recurrent melanoma', 'recurrent malignant mesothelioma', 'recurrent malignant testicular germ cell tumor', 'recurrent cervical cancer', 'recurrent ovarian epithelial cancer', 'fallopian tube cancer', 'recurrent vulvar cancer', 'recurrent vaginal cancer', 'recurrent gestational trophoblastic tumor', 'recurrent endometrial carcinoma', 'recurrent ovarian germ cell tumor', 'malignant pleural effusion'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '20068553', 'type': 'RESULT', 'citation': 'Sterman DH, Recio A, Haas AR, Vachani A, Katz SI, Gillespie CT, Cheng G, Sun J, Moon E, Pereira L, Wang X, Heitjan DF, Litzky L, June CH, Vonderheide RH, Carroll RG, Albelda SM. A phase I trial of repeated intrapleural adenoviral-mediated interferon-beta gene transfer for mesothelioma and metastatic pleural effusions. Mol Ther. 2010 Apr;18(4):852-60. doi: 10.1038/mt.2009.309. Epub 2010 Jan 12.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural cavity may improve the body's ability to fight cancer.\n\nPURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating patients who have malignant pleural mesothelioma or malignant pleural effusions.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions.\n* Determine the maximum tolerated dose of this drug in these patients.\n* Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug.\n* Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug.\n* Determine, preliminarily, tumor response in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive BG00001 via an intrapleural catheter on day 1.\n\nCohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.\n\nPatients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and then every 6 months for 15 years.\n\nPROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* One of the following histologically or cytologically confirmed diagnoses:\n\n * Malignant pleural mesothelioma\n * Metastatic malignancy to the pleural space\n\n * Originating from 1 of the following sites:\n\n * Lung\n * Breast\n * Gastrointestinal organs\n * Genitourinary organs\n * Malignant melanoma\n * Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy\n* Measurable or evaluable disease\n* Pleural space involved with tumor accessible for pleural catheter insertion\n* No malignant pleural effusions secondary to lymphoma or sarcoma\n* No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis\n* No known brain metastases\n\n * Previously treated brain metastases with no evidence of active growth are allowed\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Male or female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Granulocyte count at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hematocrit at least 30% (transfusion allowed)\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT and AST no greater than 1.5 times ULN\n* Alkaline phosphatase no greater than 1.5 times ULN\n* PT and PTT no greater than 1.5 times normal\n* No end-stage liver disease\n* No chronic active hepatitis B (hepatitis B surface antigen negative)\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL\n* No end-stage renal disease\n\nCardiovascular\n\n* No unstable angina\n\nPulmonary\n\n* FEV\\_1 greater than 50% of predicted (post-pleural drainage)\n* No severe oxygen-dependent 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 documented immunodeficiency\n* No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease\n* No other life-threatening illness\n* No known hypersensitivity to any component of study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior biologic therapy\n* No prior bone marrow transplantation, including stem cells\n* No immunological drugs during and for at least 2 months after study therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* No chemotherapy during and for at least 2 months after study therapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* Concurrent hormonal therapy allowed if maintained at dose received prior to study entry\n* No concurrent steroids\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy\n* No radiotherapy during and for at least 2 months after study therapy\n\nSurgery\n\n* At least 2 weeks since prior surgery\n\nOther\n\n* More than 4 weeks since prior cytotoxic agents\n* No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system\n* No other concurrent experimental therapies for pleural cancer'}, 'identificationModule': {'nctId': 'NCT00066404', 'briefTitle': 'Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies', 'orgStudyIdInfo': {'id': 'CDR0000315899'}, 'secondaryIdInfos': [{'id': 'UPCC-01502'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant adenovirus-hIFN-beta', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Daniel H. Sterman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}