Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT00928902
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2009-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk 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': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C094534', 'term': 'polyvalent melanoma cell vaccine'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2009-06-24', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of systemic low-dose IL-2 on the immunogenicity of a vaccine comprising synthetic melanoma peptides plus GM-CSF-in-adjuvant.'}], 'secondaryOutcomes': [{'measure': 'Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['melanoma', 'vaccine', 'peptides', 'adjuvant', 'immunogenicity', 'stage IIB, stage III or resected stage IV'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed, by cytologic or histologic examination, with AJCC stage IIB, stage III or resected stage IV melanoma.\n* Patients with up to 2 brain metastases less than or equal to 2 cm that have been surgically removed or treated successfully with the gamma-knife are eligible. Surgical resections must have been performed within 6 months prior to entry.\n* All patients must have:\n\n 1. ECOG performance status 0-1, and,\n 2. Ability and willingness to give informed consent.\n* Laboratory parameters as follows:\n\n * HLA-A1, A2 or A3 (+)\n * gp100 (+) and/or tyrosinase (+) tumor cells\n * ANC \\> 1000/mm3, and Platelets \\> 100,000 and Hgb \\> 9\n * Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN\n * Renal: Creatinine up to 1.5 x ULN\n * Serology: HIV negative, Hepatitis C negative\n\nExclusion criteria:\n\n* Patients who are currently receiving cytotoxic Chemotherapy or radiation or who have received that therapy within the preceding 4 weeks.\n* Patients with known or suspected allergies to any component of the vaccine.\n* Patients receiving the following medications at study entry or within the preceding 30 days are excluded:\n\n * Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)\n * Allergy desensitization injections\n * Corticosteroids, administered parenterally or orally - topical corticosteroids are acceptable\n* Any growth factors, Interleukin 2, Interferon alfa.\n* Prior melanoma vaccinations will not be an exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account.\n* Other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.\n* Pregnancy or the possibility of becoming pregnant during vaccine administration.\n\n * Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose.\n * Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.\n * This is consistent with existing standards of practice for vaccine and chemotherapy protocols.\n* Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.\n* Patients classified according to the New York Heart Association classification system as having Class II, III or IV heart disease.\n* Patients with active connective tissue disease requiring medication, or other severe autoimmune disease.\n* Patients who are actively hyperthyroid.\n* Patients with uncontrolled diabetes.'}, 'identificationModule': {'nctId': 'NCT00928902', 'acronym': 'MEL36', 'briefTitle': 'Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant, in Patients With High Risk Melanoma', 'orgStudyIdInfo': {'id': '8515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peptides with GM-CSF-in-adjuvant, with upfront IL-2', 'description': 'Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 1 and ending at week 7.', 'interventionNames': ['Drug: low-dose IL-2', 'Biological: melanoma vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peptides plus GM-CSF-in-adjuvant, delayed IL-2', 'description': 'Peptides plus GMCSF-in-adjuvant, with delayed IL-2.\n\nEach of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 4 and ending at week 10.', 'interventionNames': ['Drug: low-dose IL-2', 'Biological: melanoma vaccine']}], 'interventions': [{'name': 'low-dose IL-2', 'type': 'DRUG', 'description': 'low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)', 'armGroupLabels': ['Peptides plus GM-CSF-in-adjuvant, delayed IL-2', 'Peptides with GM-CSF-in-adjuvant, with upfront IL-2']}, {'name': 'melanoma vaccine', 'type': 'BIOLOGICAL', 'description': 'six melanoma vaccines given over a 6-week period', 'armGroupLabels': ['Peptides plus GM-CSF-in-adjuvant, delayed IL-2', 'Peptides with GM-CSF-in-adjuvant, with upfront IL-2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Craig L Slingluff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Craig L Slingluff MD', 'oldOrganization': 'University of Virginia'}}}}