Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 1:56 PM
Study NCT ID:
NCT00398450
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2006-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azacitidine and Interferon Alfa 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': 'D007438', 'term': 'Introns'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2006-11-09', 'studyFirstSubmitQcDate': '2006-11-09', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose'}, {'measure': 'Toxicity'}], 'secondaryOutcomes': [{'measure': 'Response'}, {'measure': 'Survival at day 1, 12 months, 3 years, and 5 years'}, {'measure': 'Relapse-free survival'}, {'measure': 'Time to relapse'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.\n* Determine if the MTD of this regimen is biologically active in these patients.\n* Define and describe the toxicities associated with this regimen.\n\nSecondary\n\n* Determine, preliminarily, the response in patients treated with this regimen.\n* Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation study of azacitidine.\n\nPatients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic melanoma\n* At least one lesion appropriate for 3 separate punch or core needle biopsies\n* Must have received and failed ≥ 1 prior systemic treatment for metastatic disease\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT \\< 2 times ULN\n* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol\n* No uncontrolled infection\n* No known HIV positivity\n* No hepatitis B or hepatitis C infection\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 3 weeks since prior systemic therapy\n* More than 4 weeks since prior radiotherapy to target lesions with evidence of progression\n* No concurrent radiotherapy to target lesions\n* No concurrent oral or IV corticosteroids\n\n * Topical creams or ocular steroid drops are allowed'}, 'identificationModule': {'nctId': 'NCT00398450', 'briefTitle': 'Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients', 'orgStudyIdInfo': {'id': 'UCSD-060199'}, 'secondaryIdInfos': [{'id': 'CDR0000511743', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'PHARMION-UCSD-060199'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant interferon alfa-2b', 'type': 'BIOLOGICAL'}, {'name': 'azacitidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Gregory A. Daniels, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gregory Daniels', 'investigatorAffiliation': 'University of California, San Diego'}}}}