Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 12:31 PM
Study NCT ID:
NCT00054535
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and 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': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-07', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2.\n* Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen.\n\nOUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR.\n\nPatients are followed annually for at least 5 years.\n\nPROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of metastatic melanoma\n\n * Measurable disease\n * Disease progression while receiving prior standard treatment\n * No ocular or mucosal primary site\n* No uncontrolled brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 16 and over\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/mm\\^3\n* Platelet count at least 90,000/mm\\^3\n* No coagulation disorders\n\nHepatic\n\n* Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)\n* AST/ALT less than 3 times normal\n* Hepatitis B surface antigen negative\n* Hepatitis C antibody negative\n\nRenal\n\n* Creatinine no greater than 1.6 mg/dL\n\nCardiovascular\n\n* No major cardiovascular illness\n\nPulmonary\n\n* No major respiratory illness\n\nImmunologic\n\n* HIV negative\n* No autoimmune disease\n* No active systemic infections\n* No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)\n* No allergy to eggs\n* No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No close contact with the following individuals for 2 weeks after vaccinia vaccination:\n\n * Children under 5 years of age\n * Pregnant women\n * Individuals with prior or active eczema or other eczematoid skin disorders\n * Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)\n * Immunosuppressed individuals\n* No active atopic dermatitis\n* No prior or active eczema\n* No active cases of the following conditions:\n\n * Extensive psoriasis\n * Severe acneiform rash\n * Impetigo\n * Varicella zoster\n * Burns\n * Traumatic or pruritic skin conditions\n * Open wounds\n* No unhealed surgical scars\n\n * Healed surgical stomas (e.g., colostomy) allowed\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior recombinant vaccinia or fowlpox vaccines for melanoma\n* No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma\n\n * Prior individual tyrosinase peptides are allowed\n* No prior high-dose interleukin-2\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* No concurrent oral, IV, topical, or inhaled steroids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Recovered from prior surgery\n\nOther\n\n* Recovered from prior therapy for melanoma\n* More than 3 weeks since prior systemic therapy for melanoma\n* No other concurrent systemic therapy for melanoma"}, 'identificationModule': {'nctId': 'NCT00054535', 'briefTitle': 'Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma', 'nctIdAliases': ['NCT00051610'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2', 'orgStudyIdInfo': {'id': 'CDR0000270794'}, 'secondaryIdInfos': [{'id': 'NCI-03-C-0080'}, {'id': 'NCI-6119'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'recombinant fowlpox-tyrosinase vaccine', 'type': 'BIOLOGICAL'}, {'name': 'vaccinia-tyrosinase vaccine', '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': 'Suzanne L. Topalian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Surgery Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}