Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00031733
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2002-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'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': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058965', 'term': 'MART-1 Antigen'}, {'id': 'C114843', 'term': "incomplete Freund's adjuvant"}, {'id': 'D053765', 'term': 'Interleukin-12 Subunit p35'}, {'id': 'C081222', 'term': 'sargramostim'}, {'id': 'D000536', 'term': 'Aluminum Hydroxide'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D058950', 'term': 'Melanoma-Specific Antigens'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000951', 'term': 'Antigens, Neoplasm'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D018664', 'term': 'Interleukin-12'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2002-03-08', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['iris melanoma', 'ciliary body and choroid melanoma, small size', 'ciliary body and choroid melanoma, medium/large size', 'extraocular extension melanoma', 'recurrent intraocular melanoma', 'stage II melanoma', 'stage III melanoma', 'stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Intraocular Melanoma', 'Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).\n\nOUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.\n* Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.\n* Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma\n\n * Resected or rendered disease-free\n* HLA-A2.1-positive by standard cytotoxicity assay\n* Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry\n\n * Must be positive for at least 1 antigen\n* Failed, ineligible for, or refused prior interferon alfa\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9.0 g/dL\n* No bleeding disorder\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n* SGOT/SGPT no greater than 2.5 times normal\n* No coagulation disorder\n* Hepatitis surface antigen B negative\n* Hepatitis C negative\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* No major cardiovascular illness\n\nPulmonary:\n\n* No major respiratory illness\n\nImmunologic:\n\n* No prior uveitis\n* No prior autoimmune inflammatory eye disease\n* No immune hemolytic anemia\n* No other active autoimmune disease\n\nOther:\n\n* HIV negative\n* No major gastrointestinal illness\n* No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago\n* No major systemic infection (e.g., pneumonia or sepsis)\n* No other major medical illness\n* No prior allergic reaction to Montanide ISA-51 or alum adjuvant\n* No requirement for steroid therapy\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* See Disease Characteristics\n* No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides\n\nChemotherapy:\n\n* At least 1 month since prior adjuvant chemotherapy for this disease\n* No concurrent adjuvant chemotherapy\n\nEndocrine therapy:\n\n* No concurrent steroids\n\nRadiotherapy:\n\n* At least 1 month since prior radiotherapy for this disease\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 1 month since other prior therapy, including adjuvant therapy, for this disease\n* No other concurrent therapy, including adjuvant therapy'}, 'identificationModule': {'nctId': 'NCT00031733', 'briefTitle': 'Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000069220 (10M-01-1)'}, 'secondaryIdInfos': [{'id': 'LAC-USC-10M011'}, {'id': 'LAC-USC-IRB-013030'}, {'id': 'NCI-5506'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MART-1 antigen', 'type': 'BIOLOGICAL'}, {'name': 'gp100 antigen', 'type': 'BIOLOGICAL'}, {'name': "incomplete Freund's adjuvant", 'type': 'BIOLOGICAL'}, {'name': 'recombinant interleukin-12', 'type': 'BIOLOGICAL'}, {'name': 'sargramostim', 'type': 'BIOLOGICAL'}, {'name': 'tyrosinase peptide', 'type': 'BIOLOGICAL'}, {'name': 'alum adjuvant', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jeffrey S. Weber, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}