Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT00016133
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2001-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001500', 'term': 'BCG Vaccine'}, {'id': 'C573235', 'term': 'FANG vaccine'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-07', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2001-05-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage II colon cancer', 'stage III colon cancer', 'adenocarcinoma of the colon'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in patients with completely resected stage II or III adenocarcinoma of the colon.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III).\n\nBeginning 28-35 days after total surgical resection, patients receive adjuvant autologous tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after surgical resection.\n\nBeginning 10-17 days after the third vaccination, patients with stage III disease receive adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every 28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1 month after the completion of chemotherapy.\n\nPatients are followed at 90 days and 6 months.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage II or III primary adenocarcinoma of the colon\n\n * Completely resected within the past 28-35 days, at which time tumor tissue is harvested for vaccine production\n * No residual or metastatic disease\n* No more than 1 malignant invasive primary colon cancer\n* No tumor originating in the rectum (i.e., inferior tumor margin must not be at or below the peritoneal reflection)\n* No perforated tumors\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 to 85\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 4,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 10.0 g/dL\n\nHepatic:\n\n* Bilirubin normal\n* SGOT normal\n* Alkaline phosphatase normal\n* No severe hepatic disease that would preclude study\n\nRenal:\n\n* Creatinine less than 1.5 times upper limit of normal\n* No severe renal disease that would preclude study\n\nCardiovascular:\n\n* No prosthetic cardiac valves\n* No recent vascular prosthesis\n* No postsurgical cardiovascular complication\n* No severe cardiovascular disease that would preclude study\n\nPulmonary:\n\n* No postsurgical pulmonary complication\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No insulin-dependent diabetes mellitus\n* No severe systemic disease that would preclude study\n* No congenital or acquired immune deficiency disease\n* No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or Turcot's syndrome\n* No ileus\n* No other prior malignancy except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix\n* No ongoing infection requiring systemic antibiotics\n* No severe postoperative complication that would preclude study\n* Carcinoembryonic antigen normal\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No other concurrent investigational immunotherapy\n\nChemotherapy:\n\n* No prior systemic chemotherapy\n* No other concurrent investigational chemotherapy\n\nEndocrine therapy:\n\n* No concurrent steroids\n\nRadiotherapy:\n\n* No prior radiotherapy\n* No concurrent investigational radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* No concurrent investigational surgery\n\nOther:\n\n* At least 3 weeks since prior systemic antibiotic therapy of more than 5 days duration (excluding topical antibiotics or perioperative prophylactic antibiotics)\n* No concurrent cytotoxic immunosuppressive agents"}, 'identificationModule': {'nctId': 'NCT00016133', 'briefTitle': 'Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer', 'orgStudyIdInfo': {'id': 'INTRACEL-ASI-2002'}, 'secondaryIdInfos': [{'id': 'CDR0000068597', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'BCG vaccine', 'type': 'BIOLOGICAL'}, {'name': 'autologous tumor cell vaccine', 'type': 'BIOLOGICAL'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18105-1556', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Michael G Hanna Jr., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Intracel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intracel', 'class': 'INDUSTRY'}}}}