Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 4:13 PM
Study NCT ID:
NCT00004050
Status:
TERMINATED
Last Update Posted:
2014-07-29
First Post:
1999-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494381', 'term': 'Leuvectin'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Development in prostate cancer indication halted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-10-28', 'lastUpdatePostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease recurrence', 'timeFrame': '2 years', 'description': 'Measure timing and rate of disease recurrence'}], 'secondaryOutcomes': [{'measure': 'Safety of Leuvectin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. Using Leuvectin to deliver this gene may be an effective treatment for prostate cancer.\n\nPURPOSE: Phase II trial to study the effectiveness of Leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Assess the toxicity and tolerability of neoadjuvant Leuvectin in patients with stage II or III prostate cancer.\n* Evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive Leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7. Between days 8 and 14, patients undergo retropubic prostatectomy.\n\nAll patients are followed at 2 months. Patients with a PSA no greater than 0.2 ng/mL are followed at 4 months and 6 months, every 3 months for 12 months, and then every 6 months for 3.5 years in the absence of disease progression or biochemical failure.\n\nACTUAL ACCRUAL: 13 patients were accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage II or III organ confined prostate cancer\n\n * Resectable disease (candidate for retropubic prostatectomy)\n* Gleason score at least 6\n* Prostate specific antigen value (PSA) at least 5 ng/mL\n* No significant central nervous system (CNS) disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 80-100%\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* White blood cell count (WBC) greater than 3,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 9.0 g/dL\n\nHepatic\n\n* Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal\n* Prothrombin time (PT)/partial thromboplastin time (PTT) normal\n* Albumin greater than 3.0 g/dL\n* Hepatitis B surface antigen negative\n\nRenal\n\n* Creatinine normal\n\nCardiovascular\n\n* No uncontrolled hypertension\n* No significant cardiovascular disease\n* No history of ventricular dysfunction or arrhythmia\n* No congestive heart failure\n* No symptoms of coronary artery disease\n* No prior myocardial infarction\n\nOther\n\n* No active autoimmune disease\n* No active infection requiring parenteral antibiotics\n* HIV negative\n* No significant psychiatric disorder that would preclude compliance\n* No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer\n* No diabetes mellitus\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for prostate cancer\n* At least 5 years since other prior chemotherapy\n\nEndocrine therapy\n\n* No prior glucocorticoids for prostate cancer\n* At least 5 years since other prior glucocorticoids\n\nRadiotherapy\n\n* No prior radiotherapy for prostate cancer\n* At least 5 years since other prior radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* At least 4 weeks since prior intrathoracic or intrabdominal surgery\n* At least 2 weeks since other major surgery\n\nOther\n\n* At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents\n* No other neoadjuvant or concurrent anticancer drugs\n* No concurrent immunosuppressive drugs\n* No other concurrent experimental therapy\n* No concurrent parenteral antibiotics'}, 'identificationModule': {'nctId': 'NCT00004050', 'briefTitle': 'Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vical'}, 'officialTitle': 'Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer', 'orgStudyIdInfo': {'id': 'VCL-1102-202'}, 'secondaryIdInfos': [{'id': 'UCLA-9901077-03B', 'type': 'OTHER', 'domain': 'UCLA'}, {'id': 'CDR0000067244', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-G99-1568', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leuvectin', 'description': '2 intratumoral injections of 1000 ug of Leuvectin', 'interventionNames': ['Biological: Leuvectin']}], 'interventions': [{'name': 'Leuvectin', 'type': 'BIOLOGICAL', 'otherNames': ['Interleukin-2 (IL-2) plasmid DNA/lipid complex'], 'description': 'Leuvectin injected intratumorally followed by prostatectomy', 'armGroupLabels': ['Leuvectin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Arie Belldegrun, MD, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}