Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 12:38 PM
Study NCT ID:
NCT00849459
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2009-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Therapy in Treating Women With Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2009-02-20', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose', 'timeFrame': 'up to 1 month', 'description': 'Serum antibodies (titer) to adenovirus'}, {'measure': 'Toxicity and safety', 'timeFrame': 'up to 2 months', 'description': 'adverse events as assessed by NCI CTCAE v3.0'}], 'secondaryOutcomes': [{'measure': 'Tumor response progression)', 'timeFrame': 'up to 2 months', 'description': 'Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)'}, {'measure': 'Immune response', 'timeFrame': 'up to 2 months', 'description': 'Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.\n* Determine the tumor response in patients treated with this regimen.\n* Determine the immune response in patients treated with this regimen.\n\nOUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.\n\nBlood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.\n\nAfter completion of study therapy, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic adenocarcinoma of the breast\n\n * Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection\n\n * Solitary or multiple tumors\n * Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan\n * Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination\n * Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination\n * Malignant disease in other organs (in addition to skin or chest wall metastases) allowed\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Karnofsky performance status 70-100%\n* Life expectancy ≥ 16 weeks\n* Granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9.0 mg/dL\n* PT normal\n* Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min\n* Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)\n* Serum transaminases ≤ 2.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)\n* No active infection or concurrent serious medical illness\n* No HIV positivity\n* No other malignancy within the past 5 years except for the following:\n\n * Inactive nonmelanoma skin cancer\n * In situ carcinoma of the cervix\n * Grade 1 papillary bladder cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)\n* No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment'}, 'identificationModule': {'nctId': 'NCT00849459', 'briefTitle': 'Gene Therapy in Treating Women With Metastatic Breast Cancer', '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 Patents With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'GCO 02-0797'}, 'secondaryIdInfos': [{'id': 'MTS-GCO-02-0797'}, {'id': 'NIH-0707-869'}, {'id': 'CDR0000629819'}]}, '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': 'Icahn Medical Center at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Max W. Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn Medical Center 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'}}}}