Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-11 @ 9:10 PM
Study NCT ID:
NCT00094003
Status:
COMPLETED
Last Update Posted:
2005-11-11
First Post:
2004-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NS-9 in Patients With Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009364', 'term': 'Neoplasm Recurrence, Local'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011070', 'term': 'Poly I-C'}], 'ancestors': [{'id': 'D011066', 'term': 'Poly C'}, {'id': 'D011131', 'term': 'Polyribonucleotides'}, {'id': 'D011119', 'term': 'Polynucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011069', 'term': 'Poly I'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2005-11-09', 'studyFirstSubmitDate': '2004-10-08', 'studyFirstSubmitQcDate': '2004-10-08', 'lastUpdatePostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-10-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Liver metastases', 'Colorectal cancer', 'Gastric cancer', 'Esophagus cancer', 'Breast cancer', 'Lung cancer', 'Skin cancer', 'Renal Cancer', 'Liver metastasis'], 'conditions': ['Liver Neoplasms', 'Neoplasm Metastasis', 'Local Neoplasm Recurrences']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.', 'detailedDescription': 'This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.\n\nAfter each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female at least 18 years of age.\n* Patients with liver metastases from various primary cancers for which no other curative treatment options exist.\n* At least one measurable lesion (by CT or MRI)\n* Life expectancy \\> 3 months\n* Child-bearing potential women must have a negative serum pregnancy test\n* ECOG performance status: 0-1\n* Fully recovered from any previous cancer therapy or infection (at least 4 weeks from radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at least 2 weeks from an exploration/biopsy)\n* Discontinued from any other investigational drug for at least 30 days\n* Serum calcium \\<11 mg/dL\n* Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support\n* Hemoglobin ≥9.0 g/dL\n* Platelet count ≥100,000/mm3\n* Serum creatinine ≤1.5 times the upper limit of normal (ULN)\n* Bilirubin ≤1.5 times ULN\n* ALT and AST ≤3 times ULN\n* Amylase and lipase ≤ ULN\n* PT and PTT \\< 1.5 times ULN\n* ECG with no acute abnormalities\n* Afebrile (≤37.5C or 99.5F)\n* Willingness and ability to comply with all study requirements\n\nExclusion Criteria:\n\n* Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.\n* Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).\n* History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).\n* New York Heart Association classification Class III or IV\n* Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.\n* Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.\n* Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.\n* Subject has received radiation to \\>25% of the total bone marrow.\n* Subject has a history of any other illness that would preclude study participation.\n* Subject has brain metastases.\n* Subject has allergy to egg yolk.\n* Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).'}, 'identificationModule': {'nctId': 'NCT00094003', 'briefTitle': 'Study of NS-9 in Patients With Liver Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'NS Pharma, Inc.'}, 'officialTitle': 'A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers', 'orgStudyIdInfo': {'id': 'NS9001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NS-9 [Poly I: Poly C]', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NS Pharma, Inc.', 'class': 'INDUSTRY'}}}}