Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-19 @ 11:27 AM
Study NCT ID:
NCT00003492
Status:
TERMINATED
Last Update Posted:
2020-12-16
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052091', 'term': 'antineoplaston A10'}, {'id': 'C092038', 'term': 'antineoplaston AS 2-1'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'srb@burzynskiclinic.com', 'phone': '713-335-5664', 'title': 'S. R. Burzynski, MD, PhD', 'organization': 'Burzynski Research Institute, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 years, 8 months', 'description': 'Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.', 'eventGroups': [{'id': 'EG000', 'title': 'Antineoplaston Therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.\n\nAntineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema/Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response or Stable Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Antineoplaston Therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.\n\nAntineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.'}], 'classes': [{'categories': [{'title': 'Stable Disease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressive Disease', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 months', 'description': 'An objective response is a complete or partial response. A complete response is complete disappearance of all tumors by physical examination and radiographic studies for a minimum duration of four weeks. A partial response is \\> 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates \\> 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of twelve weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antineoplaston Therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.\n\nAntineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Not evaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Antineoplaston Therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.\n\nAntineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'groupId': 'BG000', 'lowerLimit': '45.8', 'upperLimit': '74.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1996-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2000-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '1999-11-01', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-14', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2000-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response or Stable Disease', 'timeFrame': '16 months', 'description': 'An objective response is a complete or partial response. A complete response is complete disappearance of all tumors by physical examination and radiographic studies for a minimum duration of four weeks. A partial response is \\> 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates \\> 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of twelve weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stage IV large cell lung cancer', 'Stage IV non-small cell lung cancer'], 'conditions': ['Stage IV Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.burzynskiresearch.com', 'label': 'Burzynski Research Institute'}, {'url': 'http://www.burzynskiclinic.com', 'label': 'Burzynski Clinic'}]}, 'descriptionModule': {'briefSummary': 'Current therapies for Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer.\n\nPURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Lung Cancer.', 'detailedDescription': 'Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.\n\nOBJECTIVES:\n\n* To determine the efficacy of Antineoplaston therapy in patients with Stage IV Lung Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).\n* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Lung Cancer.\n* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed large cell, undifferentiated, or poorly differentiated stage IV lung cancer unlikely to have a curative response to existing standard regimens\n* Measurable disease by MRI or CT scan\n\n * At least 2 cm in diameter\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* WBC at least 2,000/mm\\^3\n* Platelet count at least 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 2.5 mg/dL\n* SGOT/SGPT no greater than 5 times upper limit of normal\n* No hepatic failure\n\nRenal:\n\n* Creatinine no greater than 2.5 mg/dL\n* No renal insufficiency\n* No history of renal conditions that contraindicate high dosages of sodium\n\nCardiovascular:\n\n* No severe heart disease\n* No uncontrolled hypertension\n* No history of congestive heart failure\n* No history of other cardiovascular conditions that contraindicate high dosages of sodium\n\nPulmonary:\n\n* No severe lung disease (e.g., chronic obstructive pulmonary disease)\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 4 weeks after study participation\n* No serious active infections\n* No other concurrent serious disease\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy and recovered\n* No concurrent immunomodulating agent\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n* No concurrent antineoplastic agent\n\nEndocrine therapy:\n\n* Concurrent corticosteroids allowed\n\nRadiotherapy:\n\n* At least 8 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* Recovered from prior surgery\n\nOther:\n\n* No prior antineoplaston therapy\n* Prior cytodifferentiating agent allowed'}, 'identificationModule': {'nctId': 'NCT00003492', 'briefTitle': 'Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Burzynski Research Institute'}, 'officialTitle': 'Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Large Cell, Undifferentiated Or Poorly Differentiated Stage IV Carcinoma of the Lung', 'orgStudyIdInfo': {'id': 'CDR0000066531'}, 'secondaryIdInfos': [{'id': 'BC-LA-4', 'type': 'OTHER', 'domain': 'Burzynski Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antineoplaston therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.', 'interventionNames': ['Drug: Antineoplaston therapy (Atengenal + Astugenal)']}], 'interventions': [{'name': 'Antineoplaston therapy (Atengenal + Astugenal)', 'type': 'DRUG', 'otherNames': ['A10 (Atengenal); AS2-1 (Astugenal)'], 'description': 'Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.', 'armGroupLabels': ['Antineoplaston therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77055-6330', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Burzynski Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stanislaw R. Burzynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burzynski Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burzynski Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}