Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT00019669
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy With or Without Interleukin-2 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': 'C082598', 'term': 'aldesleukin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-08', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '12912944', 'type': 'BACKGROUND', 'citation': 'Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Topalian SL, Sherry RM, Restifo NP, Wunderlich JR, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, Gritz L, Panicali DL, White DE. Recombinant fowlpox viruses encoding the anchor-modified gp100 melanoma antigen can generate antitumor immune responses in patients with metastatic melanoma. Clin Cancer Res. 2003 Aug 1;9(8):2973-80.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.\n\nPURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).\n* Compare the immune response in patients before and after treatment with these regimens.\n* Compare the toxicity profile of these regimens in these patients.\n\nOUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts.\n\n* Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)\n* Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)\n* Cohort 3 (for patients in need of immediate interleukin-2 \\[IL-2\\] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM\\* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.\n\nNOTE: \\*The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2\n\n* Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy.\n\nPROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven metastatic melanoma that has failed standard treatment\n* Measurable disease\n* HLA-A-201 positive\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 16 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC ≥ 3,000/mm\\^3\n* Platelet count ≥ 90,000/mm\\^3\n* No coagulation disorders\n\nHepatic:\n\n* Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)\n* AST/ALT \\< 2 times normal\n* Hepatitis B surface antigen negative\n\nRenal:\n\n* Creatinine ≤ 2.0 mg/dL\n\nCardiovascular:\n\n* No major cardiovascular disease\n* No cardiac ischemia by a stress thallium test or other comparable test\\*\n* No myocardial infarction\\*\n* No cardiac arrhythmias\\* NOTE: \\*In order to be eligible to receive interleukin-2 (IL-2)\n\nPulmonary:\n\n* No major respiratory disease\n* No obstructive or restrictive pulmonary disease\\* NOTE: \\*In order to be eligible to receive IL-2\n\nImmunologic:\n\n* No autoimmune disease\n* No known immunodeficiency disease\n* No primary or secondary immunodeficiency\n* No allergy to eggs\n* No active systemic infections\n* HIV negative\n\nOther:\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other active major medical illness\\* NOTE: \\*In order to be eligible to receive IL-2\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior gp100 vaccination\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent steroids\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Prior surgery for the malignancy allowed\n\nOther:\n\n* At least 3 weeks since other prior therapy for the malignancy"}, 'identificationModule': {'nctId': 'NCT00019669', 'briefTitle': 'Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma', 'nctIdAliases': ['NCT00001800'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence', 'orgStudyIdInfo': {'id': 'CDR0000066961'}, 'secondaryIdInfos': [{'id': 'NCI-99-C-0044'}, {'id': 'NCI-T98-0088'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'fowlpox virus vaccine vector', 'type': 'BIOLOGICAL'}, {'name': 'gp100 antigen', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Steven A. Rosenberg, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Surgery Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}