- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00683670
Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
21. februar 2017 oppdatert av: University of Pennsylvania
Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production.
All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells.
All patients will receive mature DC for each dose of vaccine.
For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides.
All patients will receive booster doses with mature DC.
The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses.
Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Restaging is performed after three and six vaccine doses.
Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
Studietype
Intervensjonell
Registrering (Faktiske)
17
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
- Age ≥ 18 years
- Life expectancy ≥ 4 months
- ECOG performance status 0-2
- At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
Required initial laboratory values (submitted within 14 days prior to registration):
- WBC >3,000/mm3
- Hg ≥ 9.0 gm/dl
- Platelets >75,000/mm3
- Serum Bilirubin < 2.0 mg/dl
- Serum Creatinine < 2.0 mg/dl
- Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
Exclusion Criteria:
- Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
- Active untreated CNS metastasis
- Active infection
- Prior malignancy (except non-melanoma skin cancer) within 3 years
- Pregnant or nursing
- Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
- Inability to provide adequate informed consent
- Known allergy to eggs
- Prior history or uveitis or autoimmune inflammatory eye disease.
- Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Dendritic Cell Vaccine (First Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
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Andre navn:
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Eksperimentell: Dendritic Cell Vaccine (Second Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring.
Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.
|
Andre navn:
|
Eksperimentell: Dendritic Cell Vaccine (Third Group)
Blood mononuclear cells will be collected for vaccine production through apheresis.
Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells.
Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells.
The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses.
Peripheral blood will be taken weekly to monitor the immune response.
Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.
Tidsramme: Through completion of treatment
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Through completion of treatment
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Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events
Tidsramme: 30 days after end of treatment
|
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
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30 days after end of treatment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to progression
Tidsramme: Through completion of treatment or until progressive disease
|
Through completion of treatment or until progressive disease
|
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Regulatory T cell depletion after cyclophosphamide administration.
Tidsramme: Day -3 (72 hours prior to vaccine dose 1)
|
Regulatory T cells (Treg) are defined as CD4+CD25+foxP3+ (triple positive) cells.
At the indicated time points, the percentage of Treg cells is determined by 3 color flow cytometry.
The depletion of Treg is defined as follows [Treg baseline - Treg nadir/ Treg baseline x 100= % depletion].
|
Day -3 (72 hours prior to vaccine dose 1)
|
Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.
Tidsramme: Day 0 (prior to vaccine dose 1)
|
Day 0 (prior to vaccine dose 1)
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Clinical response rate using RECIST criteria
Tidsramme: After third vaccine, sixth vaccine, and then every 8 weeks
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After third vaccine, sixth vaccine, and then every 8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gerald P. Linette, M.D., Ph.D., Abramson Cancer Center of the University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2008
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
19. mai 2008
Først innsendt som oppfylte QC-kriteriene
19. mai 2008
Først lagt ut (Anslag)
23. mai 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nevroendokrine svulster
- Nevi og melanomer
- Melanom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Cyklofosfamid
Andre studie-ID-numre
- 07-0652 / 826850
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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Mayo ClinicNational Cancer Institute (NCI)FullførtTilbakevendende melanom | Stage IV melanom | Stadium IIIA melanom | Stadium IIIB melanom | Stage IIIC melanom | Stage IIB melanom | Stage IIC melanom | Stage IIA melanomForente stater
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National Cancer Institute (NCI)FullførtStage IV melanom | Ciliary Body og Choroid Melanom, Medium/Large Størrelse | Iris melanom | Stadium IIIA melanom | Stadium IIIB melanom | Stage IIIC melanom | Ekstraokulært ekstensjonsmelanom | Stage IIB melanom | Stage IIC melanomForente stater
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAvsluttetTilbakevendende melanom | Stage IV melanom | Metastatisk intraokulært melanom | Tilbakevendende intraokulært melanom | Stage IV Intraokulært melanom | Stadium IIIA melanom | Stadium IIIB melanom | Stage IIIC melanom | Ekstraokulært ekstensjonsmelanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært... og andre forholdForente stater
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RekrutteringUopererbart melanom | Klinisk stadium III kutant melanom AJCC v8 | Melanom hos ukjent primær | Patologisk stadium IIIB kutant melanom AJCC v8 | Patologisk stadium IIIC kutant melanom AJCC v8 | Patologisk stadium IIID kutant melanom AJCC v8 | Klinisk stadium IV kutant melanom AJCC v8 | Patologisk stadium... og andre forholdForente stater
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National Cancer Institute (NCI)FullførtTilbakevendende melanom | Stage IV melanom | Stadium IIIA melanom | Stadium IIIB melanom | Stage IIIC melanom | Akralt lentiginøst malignt melanomForente stater
Kliniske studier på cyklofosfamid
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The Christie NHS Foundation TrustAvsluttetCD19 Positivt Non-Hodgkin lymfomStorbritannia
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Uprety ShraddhaPostgraduate Institute of Medical Education and ResearchUkjent
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Yonsei UniversityFullførtBrystkreftKorea, Republikken
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National Institute of Blood and Marrow Transplant...UkjentAplastisk anemi IdiopatiskPakistan
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Lagos State UniversityUkjentHematologisk abnormitetNigeria
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University of Alabama at BirminghamGenentech, Inc.; Ortho Biotech, Inc.FullførtInvasiv brystkreftForente stater
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German Breast GroupGerman Adjuvant Breast Cancer GroupFullført
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Auxilio Mutuo Cancer CenterUkjentInfiltrerende kanal- og lobulært karsinom in situ | Invasiv lobulært brystkarsinom | Inflammatorisk brystkarsinomPuerto Rico
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Memorial Sloan Kettering Cancer CenterFullførtNon-Hodgkins lymfom | CNS lymfom | CNS hjernekreftForente stater