Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT00040092
Status:
COMPLETED
Last Update Posted:
2008-01-07
First Post:
2002-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C087098', 'term': 'virulizin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-01-04', 'studyFirstSubmitDate': '2002-06-19', 'studyFirstSubmitQcDate': '2002-06-19', 'lastUpdatePostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Virulizin', 'Immunotherapy', 'Pancreas', 'Pancreatic Cancer', 'clinical trial'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '11139822', 'type': 'BACKGROUND', 'citation': 'Ferdinandi ES, Braun DP, Liu C, Zee BC, Ely G. Virulizin(R) - A review of its antineoplastic activity. Expert Opin Investig Drugs. 1999 Oct;8(10):1721-1735. doi: 10.1517/13543784.8.10.1721.'}, {'pmid': '10762639', 'type': 'BACKGROUND', 'citation': 'Liu C, Ferdinandi ES, Ely G, Joshi SS. Virulizin-2gamma, a novel immunotherapeutic agent, in treatment of human pancreatic cancer xenografts. Int J Oncol. 2000 May;16(5):1015-20. doi: 10.3892/ijo.16.5.1015.'}, {'pmid': '8174313', 'type': 'BACKGROUND', 'citation': 'Warner E, Weinroth J, Chang S, MacDonald M, Strauss B. Phase II trial of Virulizin in patients with pancreatic cancer. Clin Invest Med. 1994 Feb;17(1):37-41.'}]}, 'descriptionModule': {'briefSummary': "Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.", 'detailedDescription': 'A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.\n\nPatients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)\n* No previous systemic chemotherapy(unless given as a radiosensitizer).\n* ECOG Performance Status 0-2\n* Life expectancy equal to or greater than 12 weeks\n* Adequate laboratory and organ functions\n* Stabilizable pain (stable analgesic intake)\n* No radiotherapy during 4 weeks prior to trial entry\n* No evidence of ascites, pleural effusion or third space fluid accumulation\n* Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy'}, 'identificationModule': {'nctId': 'NCT00040092', 'briefTitle': 'A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer', 'nctIdAliases': ['NCT00045409'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Aptose Biosciences Inc.'}, 'orgStudyIdInfo': {'id': 'LOR/VIR/P03/002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Virulizin®', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aptose Biosciences Inc.', 'class': 'INDUSTRY'}}}}