Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT00301106
Status:
TERMINATED
Last Update Posted:
2017-02-02
First Post:
2006-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2006-03-08', 'studyFirstSubmitQcDate': '2006-03-08', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'up to 15 days', 'description': 'Serial monitoring of tumor necrosis factor alpha (TNFα) levels'}], 'secondaryOutcomes': [{'measure': 'Tumor Response', 'timeFrame': 'up to 2 months', 'description': 'Sequential assessment of tumor on CT or MRI'}, {'measure': 'IL12 level Immune response', 'timeFrame': 'up to 2 months', 'description': 'Serum IL12 level'}, {'measure': 'IFNγ levels Immune response', 'timeFrame': 'up to 2 months', 'description': 'IFNγ levels'}, {'measure': 'Immune response', 'timeFrame': 'up to 2 months', 'description': 'Serum antibodies (titer) to adenovirus.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'liver metastases'], 'conditions': ['Breast Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.', 'detailedDescription': 'Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).\n\nOBJECTIVES:\n\n* Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.\n* Determine tumor responses produced by this regimen.\n* Determine immune responses induced by this regimen.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed\\* breast adenocarcinoma metastatic to the liver\n\n * Solitary or multiple hepatic metastases\n\n * No malignant involvement of \\> 40% of the estimated liver volume NOTE: \\*Must be from the hepatic tumor designated for study injection\n* Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI\n* At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance\n* Extrahepatic metastasis allowed\n* No solitary hepatic metastasis eligible for liver resection\n* No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)\n* Hormone-receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* Granulocyte count ≥ 1,500/mm\\^3\n* Hemoglobin ≥ 9.0 g/dL\n* Platelet count ≥ 100,000/mm\\^3\n* PT ≤ 14.5 sec\n* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min\n* Bilirubin ≤ 2 times upper limit of normal (ULN)\n* Transaminases ≤ 2.5 times ULN\n* Karnofsky performance status ≥ 70%\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment\n* No active infection or serious intercurrent medical illness\n* No HIV infection\n* Life expectancy ≥ 16 weeks\n* No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer\n* At highest dose level, patient must weigh ≥ 30 kg\n\nPRIOR CONCURRENT THERAPY:\n\n* No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry\n\n * Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment\n* No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)'}, 'identificationModule': {'nctId': 'NCT00301106', 'briefTitle': 'Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver', 'orgStudyIdInfo': {'id': 'GCO 97-779'}, 'secondaryIdInfos': [{'id': 'MTS-GCO-97-779'}, {'id': 'MTS-9911-358'}, {'id': 'MTS-A-8200'}, {'id': 'CDR0000456626'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adenovirus-mediated human interleukin-12', 'description': 'starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.', 'interventionNames': ['Biological: adenovirus-mediated human interleukin-12']}], 'interventions': [{'name': 'adenovirus-mediated human interleukin-12', 'type': 'BIOLOGICAL', 'description': 'The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/\n\n1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.', 'armGroupLabels': ['adenovirus-mediated human interleukin-12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Max W. Sung, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max Sung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Max Sung', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}