Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT00003034
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Canada', 'Mexico', 'New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C058703', 'term': 'ranpirnase'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Objective response'}, {'measure': 'Time to best response'}, {'measure': 'Response duration'}]}, 'conditionsModule': {'keywords': ['localized malignant mesothelioma', 'advanced malignant mesothelioma', 'recurrent malignant mesothelioma'], 'conditions': ['Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.\n\nPURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of doxorubicin with or without ranpirnase in patients with malignant pleural or peritoneal mesothelioma.\n* Compare the safety profile of these regimens in these patients.\n* Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression.\n* Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed.\n\nPROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant pleural or peritoneal mesothelioma\n\n * Measurable or evaluable disease\n* CALGB groups 1-4\n* No CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,500/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* SGOT no greater than 2 times upper limit of normal\n* Bilirubin no greater than 2 mg/dL\n* PT and PTT normal\n\nRenal:\n\n* Creatinine normal\n\nCardiovascular:\n\n* No symptomatic New York Heart Association class II-IV cardiovascular disease\n* No congestive heart failure\n* No angina pectoris\n* No cardiac arrhythmias\n* No uncontrolled hypertension\n* No cerebrovascular disease\n\nMetabolic:\n\n* No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious infection\n* No uncontrolled psychosis or neurologic disease (e.g., seizure disorders)\n* No uncontrolled diabetes mellitus\n* No other primary malignancy within the past 5 years except nonmelanoma skin cancer\n* No senility or emotional instability\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No more than one prior systemic chemotherapy regimen\n* No prior doxorubicin\n* At least 6 weeks since prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy\n\nSurgery:\n\n* Prior surgical resection allowed'}, 'identificationModule': {'nctId': 'NCT00003034', 'briefTitle': 'ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen', 'orgStudyIdInfo': {'id': 'CDR0000065639'}, 'secondaryIdInfos': [{'id': 'ALFACELL-P30-302'}, {'id': 'NCI-V97-1273'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression.', 'interventionNames': ['Drug: doxorubicin hydrochloride', 'Drug: ranpirnase']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive doxorubicin as in arm I for up to 6 courses.', 'interventionNames': ['Drug: doxorubicin hydrochloride']}], 'interventions': [{'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'ranpirnase', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greenebaum Cancer Center at University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospital - Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55805-1983', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Duluth', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '68114-4199', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Estabrook Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87131-5636', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Research and Treatment Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': 'D-82131', 'city': 'Gauting', 'country': 'Germany', 'facility': 'Asklepios Fachkliniken Muenchen-Gauting', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': 'D-22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Hospital Grosshansdorf', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': 'D-20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-21075', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Harburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum Rechts Der Isar - Technische Universitaet Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'Istituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '16132', 'city': 'Genoa', 'country': 'Italy', 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione I.R.C.C.S. Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': 'PL-60 569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'University School of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-803', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Klinika Chrorob Pluc I Gruzlicy', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Diane Scudiery', 'role': 'STUDY_CHAIR', 'affiliation': 'Alfacell'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alfacell', 'class': 'INDUSTRY'}}}}