- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00683670
Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma
21 februari 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Missouri
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St. Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Andra namn:
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Experimentell: 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.
|
Andra namn:
|
Experimentell: 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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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to progression
Tidsram: Through completion of treatment or until progressive disease
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Through completion of treatment or until progressive disease
|
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Regulatory T cell depletion after cyclophosphamide administration.
Tidsram: Day -3 (72 hours prior to vaccine dose 1)
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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].
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Day -3 (72 hours prior to vaccine dose 1)
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Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.
Tidsram: Day 0 (prior to vaccine dose 1)
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Day 0 (prior to vaccine dose 1)
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Clinical response rate using RECIST criteria
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Gerald P. Linette, M.D., Ph.D., Abramson Cancer Center of the University of Pennsylvania
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2008
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
19 maj 2008
Först inskickad som uppfyllde QC-kriterierna
19 maj 2008
Första postat (Uppskatta)
23 maj 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 februari 2017
Senast verifierad
1 februari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neuroendokrina tumörer
- Nevi och melanom
- Melanom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Cyklofosfamid
Andra studie-ID-nummer
- 07-0652 / 826850
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RekryteringMetastaserande melanom | Konjunktivalt melanom | Okulärt melanom | Ooperabelt melanom | Uveal melanom | Kutant melanom | Slemhinnemelanom | Iris melanom | Akralt melanom | Icke-kutant melanomFörenta staterna
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National Cancer Institute (NCI)AvslutadÅterkommande melanom | Steg IIIA melanom | Steg IIIB melanom | Steg IIIC melanom | Steg IIB melanom | Steg IIC melanom | Steg IA melanom | Steg IB melanom | Steg IIA melanomFörenta staterna
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University of Southern CaliforniaNational Cancer Institute (NCI)AvslutadÅterkommande melanom | Steg IV melanom | Slemhinnemelanom | Ciliary Body och Choroid Melanom, Medium/Large Storlek | Ciliarkropp och koroid melanom, liten storlek | Iris melanom | Metastaserande intraokulärt melanom | Återkommande intraokulärt melanom | Steg IV Intraokulärt melanom | Steg IIIA melanom | Steg... och andra villkorFörenta staterna
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National Cancer Institute (NCI)AvslutadSteg IV melanom | Ciliary Body och Choroid Melanom, Medium/Large Storlek | Iris melanom | Steg IIIA melanom | Steg IIIB melanom | Steg IIIC melanom | Extraokulärt förlängningsmelanom | Steg IIB melanom | Steg IIC melanomFörenta staterna
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Mayo ClinicNational Cancer Institute (NCI)AvslutadÅterkommande melanom | Steg IV melanom | Steg IIIA melanom | Steg IIIB melanom | Steg IIIC melanom | Steg IIB melanom | Steg IIC melanom | Steg IIA melanomFörenta staterna
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAvslutadÅterkommande melanom | Steg IV melanom | Metastaserande intraokulärt melanom | Återkommande intraokulärt melanom | Steg IV Intraokulärt melanom | Steg IIIA melanom | Steg IIIB melanom | Steg IIIC melanom | Extraokulärt förlängningsmelanom | Steg IIIA Intraokulärt melanom | Steg IIIB Intraokulärt melanom | Steg...Förenta staterna
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RekryteringOoperabelt melanom | Kliniskt stadium III kutant melanom AJCC v8 | Melanom hos okänd primär | Patologiskt stadium IIIB kutant melanom AJCC v8 | Patologiskt stadium IIIC kutant melanom AJCC v8 | Patologiskt stadium IIID kutant melanom AJCC v8 | Kliniskt stadium IV kutant melanom AJCC v8 | Patologiskt... och andra villkorFörenta staterna
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National Cancer Institute (NCI)AvslutadÅterkommande melanom | Steg IV melanom | Steg IIIA melanom | Steg IIIB melanom | Steg IIIC melanom | Akralt lentiginöst malignt melanomFörenta staterna
Kliniska prövningar på cyklofosfamid
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National Institute of Blood and Marrow Transplant...OkändAplastisk anemi IdiopatiskPakistan