Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-30 @ 12:32 AM
Study NCT ID:
NCT00107861
Status:
COMPLETED
Last Update Posted:
2009-07-14
First Post:
2005-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-10', 'studyFirstSubmitDate': '2005-04-11', 'studyFirstSubmitQcDate': '2005-04-11', 'lastUpdatePostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Evaluate the safety of a single IV administration of Ad.hIFN-β.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.'}, {'measure': 'Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.'}, {'measure': 'Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.'}, {'measure': 'Explore preliminary clinical activity.'}]}, 'conditionsModule': {'conditions': ['Colorectal Carcinoma', 'Metastases']}, 'descriptionModule': {'briefSummary': 'This study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases. The purposes of the study are:\n\n* to evaluate the safety and any harmful effects of an intravenous injection of Ad.hIFN-β;\n* help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die.', 'detailedDescription': 'This trial is a clinical research study of Ad.hIFN-β, an investigational, replication-defective, recombinant adenovirus containing the human interferon beta gene, for people that have refractory colorectal carcinoma with liver metastases. Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases; a disease for which current treatment provides only limited relief, so there is a need for new medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma.\n* Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI).\n* Tumor progression after prior therapy for colorectal carcinoma, including fluoropyrimidine (5 FU or capecitabine), irinotecan, oxaliplatin, or cetuximab.\n* One or more metastatic hepatic tumors that is measurable on CT scan. In addition, subjects may have nonhepatic metastatic tumors.\n* ECOG performance status of ≤ 1.\n* Age ≥ 18 years.\n* Signed, written IRB-approved informed consent.\n* Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after completion of treatment.\n* Acceptable liver function:\n\n * Bilirubin ≤ 1.5 x upper limit of normal;\n * AST, ALT ≤ 2.0 x upper limit of normal;\n * Albumin ≤ 3.0 g/dL.\n* Acceptable hematologic status:\n\n * Granulocyte ≥ 1000 cells/mm3;\n * Platelet count ≥ 150,000 plts/mm3;\n * Hemoglobin \\> 9 g/dL.\n* Acceptable coagulation status: INR within normal limits.\n* Acceptable kidney function: Serum creatinine within normal limits.\n\nExclusion Criteria:\n\n* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Day 1.\n* Seizure disorders requiring anticonvulsant therapy.\n* Severe chronic obstructive pulmonary disease with hypoxemia.\n* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.\n* Active uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 1 month prior to study entry.\n* Unwillingness or inability to comply with procedures required in this protocol.\n* Known infection with HIV, hepatitis B, or hepatitis C.\n* Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.\n* Clinically significant bleeding event within the last 3 months, unrelated to trauma.\n* More than 50% of liver replaced by tumor (estimated by the PI from CT scan within 14 days of Day 1).\n* Previous treatment with Ad.hIFN-β.\n* Any prior treatment with a gene delivery vector or an adenovirus therapeutic agent.'}, 'identificationModule': {'nctId': 'NCT00107861', 'briefTitle': 'Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase I/II Study of Interferon-Beta Gene Transfer (Ad.hIFN-β) in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases', 'orgStudyIdInfo': {'id': '201-20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ad.hIFN-β (BG00001, IDEC-201)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study MD'}}}}