Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00560495
Status:
WITHDRAWN
Last Update Posted:
2022-10-03
First Post:
2007-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of 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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020809', 'term': 'tetrathiomolybdate'}, {'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D017256', 'term': 'Technetium Tc 99m Sestamibi'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015609', 'term': 'Organotechnetium Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2007-11-16', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute toxicity'}], 'secondaryOutcomes': [{'measure': 'Assessment of markers of angiogenesis in serum (VEGF, bFGF, TGF-beta, IL-6, IL-8)'}, {'measure': 'Assessment of markers of angiogenesis on imaging (technetium 99m sestamibi) scans'}, {'measure': 'Late toxicity'}, {'measure': 'Collection of response, recurrence, and survival data', 'timeFrame': 'every 3 months for up to 2 years'}]}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'large cell lung cancer', 'squamous cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects of giving radiation therapy together with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess the acute toxicity of combining antiangiogenic copper reduction with ammonium tetrathiomolybdate (TM) and standard external-beam radiotherapy in patients with stage I-IIIB non-small cell lung cancer.\n\nSecondary\n\n* To measure changes in biological markers of angiogenesis (i.e., ELISA analysis of serum bFGF, VEGF, TGF-beta, IL-6, and IL-8) affected by TM or radiotherapy and an imaging technique (technetium 99m sestamibi) known to correlate with intratumoral angiogenesis.\n* To follow the late toxicity that exists when angiogenic inhibition with the copper reduction agent TM is combined with standard external-beam radiotherapy in these patients.\n* To collect tumor response, recurrence rate, and survival data on these patients.\n\nOUTLINE:\n\n* Induction phase: Patients receive oral ammonium tetrathiomolybdate (TM) 4 times daily for up to 3 weeks.\n* Radiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6-7 weeks along with concurrent TM.\n* Maintenance phase: Patients continue to receive TM for a total of 1 year . Blood is collected periodically for analysis of laboratory outcomes by ELISA and technetium 99m sestamibi scans. Biomarkers may include VEGF, bFGF, TGF-beta, interleukin (IL)-6, and IL-8.\n\nAfter completion of study therapy, patients are followed every 3 months for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:\n\n * Squamous, large cell undifferentiated, or adenocarcinoma\n\n * Sputum cytology not acceptable evidence of cell type\n * Cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion allowed\n * Stage I-IIIB disease\n * No evidence of distant metastases\n* Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for gross residual disease or positive margin)\n* Medically inoperable disease or chemotherapy or surgery refused\n* Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan, unless definitive CT-positive mediastinal disease is noted\n\n * If patient cannot tolerate mediastinoscopy and no PET is available, the technetium 99m sestamibi scan is allowed for assessment of the mediastinum\n* No stage IIIB disease with pleural effusions or stage IV disease\n* No small cell lung cancer or mixed small cell/non-small cell histology\n\nPATIENT CHARACTERISTICS:\n\n* SWOG performance status 0-2\n* Hemoglobin ≥ 9.0 g/dL\n* WBC ≥ 3,000/mm³\n* ANC ≥ 1,200/mm³\n* Platelet count ≥ 80,000/mm³\n* Creatinine \\< 1.8 mg/dL\n* Prior malignancy allowed if disease free for ≥ 5 years\n\n * Nonmelanoma skin cancer allowed within 5 years\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the radiation oncologist has concerns about a 3-week delay in treatment)\n* No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction where the radiation oncologist has concerns about a 3-week delay in treatment)\n* No transfusion dependence requiring \\> 2 units of packed RBCs every 2 weeks for more than 28 days\n* No medically serious acute or chronic medical condition that is unstable and/or requires intensive management\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior thoracic radiation allowed if the new lesion can be treated with absolutely no overlap of previous treatment fields\n* At least 3 weeks since prior surgery\n* No concurrent chemotherapy'}, 'identificationModule': {'nctId': 'NCT00560495', 'briefTitle': 'Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'The Combination of Radiotherapy With the Anti-Angiogenic Agent Tetrathiomolybdate (TM) in the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase I Study', 'orgStudyIdInfo': {'id': 'CDR0000574135'}, 'secondaryIdInfos': [{'id': 'RPCI-EPR-38104'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ammonium tetrathiomolybdate', 'type': 'DRUG', 'description': '4 times daily for up to 3 weeks'}, {'name': 'immunoenzyme technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'Tc 99m sestamibi', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'once daily, 5 days a week, for 6-7 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Mohammad K. Khan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}