Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT00056134
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2003-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2003-03-06', 'studyFirstSubmitQcDate': '2003-03-06', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by clinical and laboratory evaluation at every visit'}, {'measure': 'Overall survival as assessed by clinical staging (CT scan and positron emission tomography [PET]) every 3 months'}], 'secondaryOutcomes': [{'measure': 'Depletion of regulatory T-cells as assessed by tetramer stainings at every visit'}, {'measure': 'Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit'}, {'measure': 'Time to progression as assessed by clinical staging (CT scan and PET) every 3 months'}, {'measure': 'Objective response rate as assessed by clinical staging (CT scan and PET) every 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage IV melanoma', 'stage IIIA melanoma', 'stage IIIB melanoma', 'stage IIIC melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'availIpds': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23958949', 'type': 'Publication', 'comment': 'Denileukin diftitox (ONTAK) induces a tolerogenic phenotype in dendritic cells and stimulates survival of resting Treg.\n\nBaur AS1, Lutz MB, Schierer S, Beltrame L, Theiner G, Zinser E, Ostalecki C, Heidkamp G, Haendle I, Erdmann M, Wiesinger M, Leisgang W, Gross S, Pommer AJ, Kämpgen E, Dudziak D, Steinkasserer A, Cavalieri D, Schuler-Thurner B, Schuler G.'}, {'id': 'DOI:10.1182/blood-2012-09-4569', 'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23958949', 'type': 'Clinical Study Report', 'comment': 'Denileukin diftitox (ONTAK) induces... Baur AS et al'}], 'references': [{'pmid': '23958949', 'type': 'DERIVED', 'citation': 'Baur AS, Lutz MB, Schierer S, Beltrame L, Theiner G, Zinser E, Ostalecki C, Heidkamp G, Haendle I, Erdmann M, Wiesinger M, Leisgang W, Gross S, Pommer AJ, Kampgen E, Dudziak D, Steinkasserer A, Cavalieri D, Schuler-Thurner B, Schuler G. Denileukin diftitox (ONTAK) induces a tolerogenic phenotype in dendritic cells and stimulates survival of resting Treg. Blood. 2013 Sep 26;122(13):2185-94. doi: 10.1182/blood-2012-09-456988. Epub 2013 Aug 19.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma cells. Combining vaccine therapy with biological therapy may kill more tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with denileukin diftitox in treating patients who have stage III or stage IV melanoma.", 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides with or without ex vivo CD40-ligand and denileukin diftitox, in terms of tumor-specific T-cell response, in patients with HLA-A1- and/or HLA-A2.1-positive stage III or IV melanoma.\n* Determine the safety and tolerability of these vaccinations in these patients.\n* Determine tumor response in patients treated with these vaccinations.\n\nOUTLINE:\n\n* Phase I (Administration of denileukin diftitox and vaccinations #1 to #4): Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PMBC). PBMC are processed for the generation of dendritic cells (DC) to be used for vaccinations. DC are pulsed with HLA-A1- and HLA-A2.1-restricted peptides derived from melanoma-associated tumor antigens. DC are pulsed with or without ex vivo treatment with CD40-ligand. Patients receive denileukin diftitox IV for 3 consecutive days before the first vaccination. Patients receive 4 pulsed DC vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease progression or unacceptable toxicity.\n\nPatients who show a tumor response (at least stable disease) may receive vaccination #5 and further booster vaccinations.\n\n* Phase II: DC are generated and pulsed as in phase I. Patients receive up to 6 additional booster pulsed DC vaccinations SC on days 126, 184, 268, 356, 520, and 692 in the absence of disease progession or unacceptable toxicity.\n\nPatients are followed for 10 years.\n\nPROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed locoregional or metastatic cutaneous malignant melanoma\n\n * Stage III or IV disease\n\n * Stage III: pT4b, N0, M0 (satellite metastases) or any pT, N1 or pT, N1 or N2a-c, M0 (lymph node metastases or in transit intralymphatic metastases)\n * Stage IV: any pT, N1-2, M1a-b\n * Surgically incurable\n * Incurable with standard treatment (i.e., localized chemotherapy/limb perfusion for stage III, systemic chemotherapy for stage IV)\n* Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or non-invasive radiologic procedures NOTE: Stage III lesions may be measurable lymph nodes after incomplete resection and/or inoperable in transit metastases\n* HLA-A1 and/or HLA-A2 expression by serologic HLA typing\n\n * HLA-A2.01 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells\n* No active CNS metastases\n\n * Previously treated CNS metastases (e.g., excision of a single metastasis) allowed if no active disease present by CT scan or MRI\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 6 months\n\nHematopoietic\n\n* WBC greater than 2,500/mm\\^3\n* Neutrophil count greater than 1,000/mm\\^3\n* Lymphocyte count greater than 700/mm\\^3\n* Platelet count greater than 75,000/mm\\^3\n* Hemoglobin greater than 9 g/dL\n* No bleeding disorders\n\nHepatic\n\n* Bilirubin less than 2.0 mg/dL\n* No hepatitis B or C\n\nRenal\n\n* Creatinine less than 2.5 mg/dL\n\nCardiovascular\n\n* No clinically significant heart disease\n\nPulmonary\n\n* No clinically significant respiratory disease\n\nImmunologic\n\n* No active systemic infection\n* No immunodeficiency disease\n\n * No evidence of HIV-1, HIV-2, or human T-cell lymphocytic virus-1\n* No active autoimmune disease including, but not limited to:\n\n * Lupus erythematosus\n * Autoimmune thyroiditis or uveitis\n * Multiple sclerosis\n * Inflammatory bowel disease NOTE: Vitiligo allowed\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 4 weeks after study participation\n* No organic brain syndrome or significant psychiatric abnormality that would preclude study participation and follow-up\n* No contraindication to leukapheresis\n* No other active malignant neoplasms\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior systemic immunotherapy\n* No concurrent immunotherapy during and for 2 weeks after last vaccination\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas \\[e.g., fotemustine\\])\n* No concurrent chemotherapy during and for 2 weeks after last vaccination\n\nEndocrine therapy\n\n* No concurrent corticosteroids during and for 2 weeks after last vaccination\n\nRadiotherapy\n\n* No prior radiotherapy to the spleen\n* Concurrent palliative radiotherapy allowed for selected metastases (e.g., pain or local complications such as compression)\n\nSurgery\n\n* See Disease Characteristics\n* Recovered from prior surgery\n* No prior splenectomy\n* No prior organ allografts\n* Concurrent surgery of selected metastases (e.g., pain or local complications such as compression) allowed\n\nOther\n\n* No other concurrent investigational drugs during and for 2 weeks after last vaccination\n* No concurrent paramedical substance during and for 2 weeks after last vaccination\n* No concurrent participation or intent to participate in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00056134', 'briefTitle': 'Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Erlangen'}, 'officialTitle': 'Vaccination of HLA-A1 and/or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide-Loaded Autologous Dendritic Cells With Prior Depletion of CD25-Positive Cells Using Denileukin Difitox (ONTAK)', 'orgStudyIdInfo': {'id': 'CDR0000270762'}, 'secondaryIdInfos': [{'id': 'ERLANGEN-ONTAK'}, {'id': 'EU-20246'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Dendritic cell vaccine plus denileukin difitox', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Gerold Schuler', 'role': 'STUDY_CHAIR', 'affiliation': 'Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'PD Dr. med. univ. Beatrice Schuler-Thurner', 'investigatorAffiliation': 'University Hospital Erlangen'}}}}