Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 10:05 AM
Study NCT ID:
NCT00022568
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C439566', 'term': 'rV-Tricom'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma.\n* Determine the clinical toxic effects of this vaccine in these patients.\n* Determine the safety of this vaccine in these patients.\n* Determine the clinical response of these patients to this vaccine.\n* Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations.\n\nCohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.\n\nQuality of life is assessed at baseline, at each vaccine administration, and at study completion.\n\nPatients are followed at 3 months.\n\nPROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma\n* Lesion(s) must be accessible to percutaneous injection\n* Measurable lesion(s)\n\n * At least 1.0 cm\n* Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed\n\n * At least 6 weeks since prior definitive therapy (surgery or radiotherapy)\n* No untreated or edematous metastatic brain lesions or leptomeningeal disease\n* No ascites or pleural effusions\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm3\n* Platelet count at least 100,000/mm3\n* Absolute granulocyte count at least 3,000/mm3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Direct bilirubin no greater than 1.5 mg/dL\n* Transaminases no greater than 2 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2 times ULN\n* No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)\n* No hepatic insufficiency\n* No alcoholic cirrhosis\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n* No renal insufficiency\n\nCardiovascular:\n\n* No congestive heart failure\n* No serious cardiac arrhythmias\n* No evidence of recent prior myocardial infarction on EKG\n* No clinical coronary artery disease\n\nPulmonary:\n\n* No chronic obstructive pulmonary disease\n\nImmunologic:\n\n* No prior eczema\n* HIV negative\n* No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)\n* No clinical or laboratory evidence of an underlying immunosuppressive disorder\n* No active or chronic infections\n* No significant allergy or hypersensitivity to eggs\n\nOther:\n\n* No active seizure disorders\n* No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free\n* No evidence of bone marrow toxicity\n* No other concurrent medical illness that would preclude study\n* No other contraindications to vaccinia virus administration\n* No encephalitis\n* Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior vaccinia immunization required (e.g., smallpox vaccination)\n* More than 8 weeks since prior immunotherapy and recovered\n* No prior therapy with live vaccinia virus vector\n\nChemotherapy:\n\n* More than 4 weeks since prior chemotherapy and recovered\n\nEndocrine therapy:\n\n* At least 4 weeks since prior systemic corticosteroids\n* No concurrent systemic corticosteroids\n* No concurrent steroids\n\nRadiotherapy:\n\n* See Disease Characteristics\n* More than 2 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* See Disease Characteristics\n* More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered\n\nOther:\n\n* No concurrent immunosuppressive drugs'}, 'identificationModule': {'nctId': 'NCT00022568', 'briefTitle': 'Vaccine Therapy in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000068831'}, 'secondaryIdInfos': [{'id': 'CPMC-IRB-14387'}, {'id': 'AECM-01-003'}, {'id': 'NCI-3353'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant vaccinia-TRICOM vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], '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'}]}}}