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- Klinische proef NCT00074230
Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens
RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma.
- Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine.
- Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients.
Secondary
- Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine.
OUTLINE: This is an open-label, nonrandomized study.
- Phase I: Beginning 9-11 days before vaccination, patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are processed for the generation of dendritic cells (DC) to be used for vaccinations. PBMCs are transfected with RNAs encoding for Melan-A, MAGE-3, and survivin antigens. DC are pulsed with keyhole limpet hemocyanin (KLH) for some patients.
Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may proceed to the phase II portion of the study.
- Phase II: Patients undergo leukapheresis as in phase I on days 102, 354, and 690. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127, 185, 269, 356, 521, and 692.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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Erlangen, Duitsland, D-91052
- Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous* melanoma
- Stage IV
- Incurable by surgical resection
- Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
- Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures
No active CNS metastases by CT scan or MRI
- Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: *Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 4 months
Hematopoietic
- WBC greater than 2,500/mm^3
- Neutrophil count greater than 1,000/mm^3
- Lymphocyte count greater than 700/mm^3
- Platelet count greater than 75,000/mm^3
- Hemoglobin greater than 9 g/dL
- No bleeding disorder
Hepatic
- Bilirubin less than 2.0 mg/dL
- No evidence of hepatitis B or C infection
Renal
- Creatinine less than 2.5 mg/dL
Cardiovascular
- No clinically significant heart disease
Pulmonary
- No respiratory disease
Immunologic
- HIV-1 and HIV-2 negative
- HTLV-1 negative
- No active systemic infection
- No immunodeficiency disease
No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease)
- Vitiligo allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- Stable medical condition
- No other major serious illness
- No contraindication to leukapheresis
- No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up
- No other active malignant neoplasm
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy
- No other concurrent immunotherapy during and for 2 weeks after study participation
Chemotherapy
- More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine])
- No concurrent chemotherapy during and for 2 weeks after study participation
Endocrine therapy
- No concurrent corticosteroids during and for 2 weeks after study participation
Radiotherapy
- More than 2 weeks since prior radiotherapy
- No prior radiotherapy to the spleen
- Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed
Surgery
- Recovered from prior surgery
- No prior splenectomy
- No prior organ allografts
Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed
- Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules)
Other
- No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation
- No concurrent participation in another clinical trial
- Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Safety and tolerability at every visit
Tijdsspanne: 3 months
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3 months
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Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months
Tijdsspanne: 3 months
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Time to progression as assessed by clinical staging (CT scan, PET) every 3 months
Tijdsspanne: 3 months
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3 months
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Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months
Tijdsspanne: 3 months
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3 months
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Duration of response as assessed by clinical staging (CT scan, PET) every 3 months
Tijdsspanne: 3 months
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3 months
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Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit
Tijdsspanne: 3 months
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3 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gerold Schuler, Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Nevi en melanomen
- Melanoma
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Proteaseremmers
- Cysteïneproteïnaseremmers
- BIRC5-eiwit, mens
Andere studie-ID-nummers
- ERLANGEN-DERMA-ER-DC-06
- CDR0000343699 (Register-ID: PDQ (Physician Data Query))
- EU-20317
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Melanoom (Huid)
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Utah State UniversityActief, niet wervendOntvelling (skin-picking) stoornisVerenigde Staten
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Ritamaria Di LorenzoVoltooidSKIN ADAPTOGEN EN SEBUM BALANCE EFFICIËNTIEItalië
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Northwestern UniversityUniversity of Wisconsin, StoutVoltooidPerceptie van Skin of Color Clinics bij Afro-AmerikanenVerenigde Staten
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Karolinska InstitutetRegion StockholmVoltooidTrichotillomanie | Ontvelling (skin-picking) stoornisZweden
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National Taiwan University HospitalOnbekend
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The Netherlands Cancer InstituteOnbekendStadium IV huidmelanoom | Oog; MelanomaNederland
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University of AarhusDanish Cancer Society; AmbuFlexVoltooidMelanoma | Kwaliteit van het levenDenemarken
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Herlev HospitalVoltooidMelanoma | HuidkankerDenemarken
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Herlev HospitalVoltooidGeïntegreerde basiswetenschap binnen het instructieontwerp van patroonherkenningstraining (AISC-ISF)Melanoma | HuidkankerDenemarken
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University Medical Center GroningenWervingMelanoma | Hoofd- en nekneoplasmata | MSI-H-kankerNederland