Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 9:48 PM
Study NCT ID:
NCT00045357
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Therapy 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-20', 'studyFirstSubmitDate': '2002-09-06', 'studyFirstSubmitQcDate': '2003-07-07', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': "RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma.\n* Determine the safety and toxicity of this regimen in these patients.\n* Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients.\n\nSecondary\n\n* Determine the antitumor effects of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100.\n\nPatients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes.\n\nCohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells 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\nPatients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks.\n\nPROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic melanoma\n* HLA type expressing one of the following class II alleles:\n\n * DRB1\\*0401\n * DRB1\\*0404\n * DRB1\\*1501\n * DPB1\\*0401\n * DPB1\\*0402\n* Tumor expresses tyrosinase\n* Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed\n* No CNS metastases\n\n * Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 75\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* More than 16 weeks\n\nHematopoietic\n\n* WBC greater than 4,000/mm\\^3\n* Absolute neutrophil count greater than 2,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hematocrit greater than 30%\n\nHepatic\n\n* SGOT no greater than 3 times upper limit of normal\n* INR no greater than 1.5 due to hepatic dysfunction\n* No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n* Calcium no greater than 12 mg/dL\n\nCardiovascular\n\n* No significant cardiac abnormalities\\*, defined by any 1 of the following:\n\n * Congestive heart failure\n * Clinically significant hypotension\n * Symptoms of coronary artery disease\n * Cardiac arrhythmias present on EKG requiring drug therapy NOTE: \\*Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram\n\nPulmonary\n\n* No clinically significant pulmonary dysfunction\n* FEV1 at least 1.0 L OR\n* FEV1 at least 60%\n* DLCO at least 55% (corrected for hemoglobin)\n\nImmunologic\n\n* No acquired or hereditary immunodeficiency\n* No autoimmune disease\n* No active infection\n* No oral temperature greater than 38.2 degrees C within the past 72 hours\n* No systemic infection requiring chronic maintenance or suppressive therapy\n* HIV negative\n\nOther\n\n* No retinitis or choroiditis\n* No history of seizures\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy)\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy (standard or experimental) and recovered\n\nEndocrine therapy\n\n* No concurrent systemic steroids except for toxicity management\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 4 weeks since prior immunosuppressive therapy\n* More than 4 weeks since prior experimental drugs and recovered\n* No concurrent pentoxifylline\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00045357', 'briefTitle': 'Biological Therapy in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma', 'orgStudyIdInfo': {'id': '1585.00'}, 'secondaryIdInfos': [{'id': 'FHCRC-1585.00'}, {'id': 'NCI-H02-0093'}, {'id': 'CDR0000256867', 'type': 'REGISTRY', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic autologous lymphocytes', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Cassian Yee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}