Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-01 @ 4:39 AM
Study NCT ID:
NCT00027833
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-09', 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '2001-12-07', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '18676757', 'type': 'RESULT', 'citation': 'Kaufman HL, Lenz HJ, Marshall J, Singh D, Garett C, Cripps C, Moore M, von Mehren M, Dalfen R, Heim WJ, Conry RM, Urba WJ, Benson AB 3rd, Yu M, Caterini J, Kim-Schulze S, Debenedette M, Salha D, Vogel T, Elias I, Berinstein NL. Combination chemotherapy and ALVAC-CEA/B7.1 vaccine in patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Aug 1;14(15):4843-9. doi: 10.1158/1078-0432.CCR-08-0276.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines 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. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma.\n* Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks.\n\nTwo weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\n* Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I.\n* Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy, patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once weekly on weeks 1-3 and 6.\n\nPROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic colorectal adenocarcinoma\n* No clinically active CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* More than 6 months\n\nHematopoietic:\n\n* Lymphocyte count at least 1,000/mm\\^3\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* AST/ALT less than 3 times ULN (5 times ULN if liver metastases present)\n* Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present)\n* No hepatocellular dysfunction\n* No cirrhosis\n\nRenal:\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular:\n\n* No uncontrolled coronary artery disease\n* No symptomatic congestive heart failure\n\nPulmonary:\n\n* No uncontrolled chronic obstructive lung disease\n\nGastrointestinal:\n\n* No unsolved bowel obstruction or subobstruction\n* No uncontrolled Crohn's disease\n* No ulcerative colitis\n* No concurrent chronic diarrhea\n\nImmunologic:\n\n* HIV negative\n* No immunocompromised patients\n* No diagnosis of altered immune function, including:\n\n * Lupus erythematosus\n * Sjogren's syndrome\n * Scleroderma\n * Myasthenia gravis\n * Goodpasture's disease\n * Addison's disease\n * Hashimoto's thyroiditis\n * Active Graves' disease\n* No known allergy to egg products or neomycin\n* No prior adverse reaction to tetanus toxoid-containing vaccines\n\nOther:\n\n* No significant comorbid medical function\n* No uncontrolled infection\n* No unstable diabetes mellitus\n* No uncontrolled thyroid function abnormalities\n* No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix\n* No other medical illness or mental status that would preclude study participation\n* No prior severe toxicity to adjuvant chemotherapy\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 3 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior CEA-directed immunotherapy\n* No other concurrent immunotherapy\n\nChemotherapy:\n\n* At least 6 months since prior adjuvant chemotherapy\n* No prior chemotherapy for metastatic disease\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent daily use of systemic steroids\n* No concurrent nonsubstitutional hormonal therapy\n\nRadiotherapy:\n\n* No prior radiotherapy to more than 50% of all nodal groups\n* No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve\n\nSurgery:\n\n* No prior major organ allograft\n* Recovered from prior surgery\n\nOther:\n\n* At least 28 days since prior investigational products\n* No other concurrent investigational products"}, 'identificationModule': {'nctId': 'NCT00027833', 'briefTitle': 'Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CDR0000069082'}, 'secondaryIdInfos': [{'id': 'CPMC-14534'}, {'id': 'CPMC-BB-IND-9911'}, {'id': 'FCCC-01015'}, {'id': 'APL-COL13'}, {'id': 'NCI-G01-2033'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ALVAC-CEA-B7.1 vaccine', 'type': 'BIOLOGICAL'}, {'name': 'tetanus toxoid', 'type': 'BIOLOGICAL'}, {'name': 'FOLFIRI regimen', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033-0804', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97213-2967', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Earle A. Chiles Research Institute at Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18510', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scranton Hematology-Oncology', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Howard L. Kaufman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Irving Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}