Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT00253461
Status:
TERMINATED
Last Update Posted:
2012-03-20
First Post:
2005-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
11C Topotecan PET Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D001932', 'term': 'Brain 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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Drugs unavailable:unable to make radioactive topotecan', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2005-11-11', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics on day of positron-emission tomography scan', 'timeFrame': 'Within 1 week of PET'}, {'measure': 'Disease response', 'timeFrame': 'after 1-2 courses of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV ovarian epithelial cancer', 'stage IV ovarian germ cell tumor', 'extensive stage small cell lung cancer', 'recurrent small cell lung cancer', 'unspecified adult solid tumor, protocol specific', 'recurrent ovarian epithelial cancer', 'recurrent ovarian germ cell tumor', 'tumors metastatic to brain'], 'conditions': ['Lung Cancer', 'Metastatic Cancer', 'Ovarian Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.\n\nPURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine if tumor uptake of \\^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.\n* Determine, preliminarily, if \\^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.\n\nSecondary\n\n* Determine the whole-body biodistribution of \\^11C topotecan in these patients.\n\nOUTLINE:\n\n* Phase I: Patients receive \\^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.\n* Phase II: Patients receive \\^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.\n\nPROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian cancer, small cell lung cancer, or other cancers\n\n * Metastatic brain disease\n* Eligible for topotecan therapy\n* Measurable disease by CT scan and/or MRI\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* WBC ≥ 3,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Creatinine clearance ≥ 50 mL/min\n\nOther\n\n* Not pregnant or nursing\n* Adequate end-organ function\n* Able to tolerate lying on a radiology table for ≥ 1 hour\n* No serious medical or psychiatric illness that would preclude study compliance or giving informed consent\n\nPRIOR CONCURRENT THERAPY: Not specified'}, 'identificationModule': {'nctId': 'NCT00253461', 'briefTitle': '11C Topotecan PET Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian, Small Cell Lung, or Other Cancer', 'orgStudyIdInfo': {'id': 'CWRU6Y02'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CWRU-6Y02', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'computed tomography', 'type': 'PROCEDURE', 'description': 'Within 4 weeks after initial imaging, patients also undergo a CT scan.'}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'description': 'Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan.\n\nPhase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.'}, {'name': '11C topotecan', 'type': 'RADIATION', 'description': 'Phase I and II: IV over 10 minutes'}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION', 'description': 'Phase II: fludeoxyglucose F 18 IV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Raymond Muzic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}