- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01760499
Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study
18 april 2017 uppdaterad av: H. Lee Moffitt Cancer Center and Research Institute
The main purpose of this study is to find out more about how PV-10 works in melanoma tumors.
Researchers also want to find out if there are changes in the body's immune cells (cells that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and circulating in the blood.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
15
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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Florida
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Tampa, Florida, Förenta staterna, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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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:
- Patients who are diagnosed with metastatic melanoma, or who are suspected to have metastatic melanoma and are subsequently proven to have metastatic melanoma by biopsy
- Patients who are planned to undergo surgical resection of at least two foci of palpable cutaneous or subcutaneous metastatic melanoma, for either palliative or therapeutic intent and who consent for preoperative core biopsies of at least two of the resectable lesions prior to surgery
- Patients who have given informed consent to participate in the study
Exclusion Criteria:
- Patients who decline consent for this study
- Patients who have previously received PV-10 therapy
- Patients who were suspected to have metastatic melanoma but are not proven by preoperative biopsy will be replaced and not counted against the accrual goal
- Patients who do not undergo surgical resection of at least two metastatic melanoma lesions including the PV-10 treated lesion will be replaced and not counted against the accrual goal.
- Patients whose melanoma lesions are contiguous with, encompass or infiltrate a major blood vessel
- Patients with an allergy to shellfish due to reported cross-reactivity to PV-10
- Patients with previous sensitivity to iodide
- Patients who do not have a treatable target lesion on a portion of the body other than the head or neck
Concurrent or Intercurrent Illness:
- Patients with a condition of impaired wound healing (such as uncontrolled diabetes mellitus or immunosuppressive steroid dependence) such that in the opinion of the PI it is unsafe for the patient to undergo intralesional PV-10 treatment
- Patients with severe peripheral vascular disease (i.e., claudication occurring after less than 200 meters of walking, rest pain, ischemic ulceration or gangrene)
- Patients with significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the principal investigator (PI), compromise their safety or compliance or interfere with interpretation of study results
- Patients with uncontrolled thyroid disease, goiter, partial thyroidectomy, previous radioiodine or surgically-treated Graves' hyperthyroidism or cystic fibrosis
- Patients with clinically significant cardiovascular, cerebrovascular, peripheral vascular, renal, gastrointestinal, pulmonary, immunological, endocrine, bone marrow or central nervous system disorders that have required hospitalization within the past 12 months
Pregnancy
- Female patients who have a positive pregnancy test or are lactating.
- Fertile patients who do not agree to use effective contraception (i.e., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures) beginning at the time of signing consent until after surgery.
- Patients who are dependent upon concomitant medications that predispose to photosensitivity who cannot stop the medication(s) from the period starting 24 hours prior to and ending 24 hours after PV-10 treatment will be excluded.
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Immunotherapy Followed by Surgery
PV-10 administration, adverse events assessment, surgery to remove melanoma tumors, follow-up visit.
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PV-10 administration: Within one week after completing the screening tests (or the same day as the screening tests), participants will be scheduled to have the study drug (PV-10) administered.
PV-10 is given as an injection with a needle, directly into one of the participant's tumors.
Participants will be given an injection of a numbing medication before the PV-10 is given.
Andra namn:
Surgery to remove melanoma tumors (Day 7-14): About 7-14 days after the PV-10 is given, participants will have surgery to remove their melanoma tumors.
A piece of the tumor that was injected with PV-10 along with a piece of one other tumor will be sent to the laboratory for testing as part of the study.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Occurrence of Change in Infiltration of Immune Cells
Tidsram: At baseline and 7-14 days after PV-10 treatment
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The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples.
Tumor core needle biopsies will be collected from the designated injected and uninjected lesions one week prior to intralesional PV-10 therapy.
Biopsy samples will be fixed in formalin and embedded in paraffin for immunohistochemical (IHC) staining.
On day 0, the injected lesion will be treated with up to 5 mL of PV-10.
Seven to 14 days after intralesional PV-10 treatment, the injected and uninjected lesions will be resected.
A portion of each tumor equivalent to a core needle biopsy specimen will be fixed in formalin and embedded in paraffin for IHC staining.
Immune cell infiltration will be compared between untreated baseline lesions and post-treatment lesions (injected or uninjected) by a blinded pathologist at Moffitt Cancer Center.
Measurement is the ordinal level of the T-cell infiltration into tumors with three levels: 0, no brisk, and brisk.
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At baseline and 7-14 days after PV-10 treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Frequency and Phenotype of Circulating Immune Cells in Peripheral Blood Mononuclear Cells (PBMC)
Tidsram: At baseline, 7-14 days after treatment and 21-28 days after treatment
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This secondary endpoint is to enumerate and phenotype patient immune cells in peripheral blood before and after intralesional (IL) PV-10 treatment.
The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples.
T cells will be enumerated and phenotyped in patient blood one week prior to and 7-14 days after intralesional PV-10 therapy.
An additional blood draw 14 days post surgery will take place at the end of the study at the time of the surgical follow-up/end of study visit.
These samples will be used for in vitro experiments in order to determine the frequency and phenotype of T cells in the blood by flow cytometry.
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At baseline, 7-14 days after treatment and 21-28 days after treatment
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Titer of Anti-tumor IgG in the Serum
Tidsram: At baseline, 7-14 days after treatment and 21-28 days after treatment
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This secondary endpoint is to enumerate anti-tumor immunoglobulin G (IgG) in peripheral blood before and after IL PV-10 treatment.
Titer of anti-tumor IgG in the serum prior to, 7-14 days after, and 21-28 days after PV-10 treatment.
The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples.
Serum will be phenotyped from patients one week prior to, 7-14 days after and 21-28 days after IL PV-10 therapy.
Serum will be isolated from peripheral blood by centrifugation and will be used to stain patient tumor samples obtained from surgical resection.
Bound serum antibodies will be detected by staining with antihuman IgG antibodies and detected by flow cytometry.
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At baseline, 7-14 days after treatment and 21-28 days after treatment
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Occurrence of Adverse Events (AEs)
Tidsram: During PV-10 administration visit, after 7-14 days, at study end (day 28 or early termination)
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Local and systemic toxicity signs and symptoms per the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Any adverse experiences associated with participation on the trial will be recorded.
Adverse events will be assessed within 30 minutes following PV-10 administration and 4 hours after PV-10 administration.
Adverse events assessment: Questions about how participants have been feeling and any changes in the way participants feel immediately after the study drug was given and 4 hours later.
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During PV-10 administration visit, after 7-14 days, at study end (day 28 or early termination)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Amod A. Sarnaik, M.D., H. Lee Moffitt Cancer Center and Research Institute
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.
Användbara länkar
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
24 januari 2013
Primärt slutförande (Faktisk)
29 december 2015
Avslutad studie (Faktisk)
1 april 2017
Studieregistreringsdatum
Först inskickad
21 december 2012
Först inskickad som uppfyllde QC-kriterierna
2 januari 2013
Första postat (Uppskatta)
4 januari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 april 2017
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MCC-17183
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 .
Kliniska prövningar på Melanom
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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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MelanomaPRO, RussiaRekryteringMelanom | Melanom (hud) | Melanom Steg IV | Melanom stadium III | Melanom, stadium II | Melanom, Uveal | Melanom in Situ | Melanom, OkulärRyska Federationen
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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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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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BiocadRekryteringMelanom | Melanom (hud) | Melanom Steg IV | Melanom stadium III | Melanom Metastaserande | Melanom ooperabelt | Melanom AvanceratIndien, Ryska Federationen, Belarus
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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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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
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Provectus Biopharmaceuticals, Inc.Inte längre tillgängligKutana eller subkutana tumörer där det inte finns någon jämförbar eller tillfredsställande | Godkänd alternativ terapiFörenta staterna, Australien
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Provectus PharmaceuticalsAvslutad
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Provectus PharmaceuticalsAvslutad
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Provectus Biopharmaceuticals, Inc.Aktiv, inte rekryterandeMetastaserande kolorektal cancer | Hepatocellulärt karcinom | Metastaserande lungcancer | Metastaserad bröstcancer | Metastaserande melanom | Metastaserande Uveal melanom | Metastaserad pankreascancer | Metastaserande tjocktarmscancer | Metastaserande okulärt melanom | Cancer Metastaserande till levernFörenta staterna
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Provectus Biopharmaceuticals, Inc.Aktiv, inte rekryterandeNeuroendokrina tumörer som metastaserar i levernAustralien
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Yonsei UniversityRekryteringParoxysmalt förmaksflimmerKorea, Republiken av
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Meshalkin Research Institute of Pathology of CirculationAvslutadFörmaksflimmer | Arteriell hypertoniRyska Federationen, Förenta staterna, Grekland
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Staedtisches Klinikum KarlsruheHeidelberg UniversityAvslutad
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Krasnoyarsk Regional HospitalOkändPatologiska processer | Hjärtsjukdom | Hjärt-kärlsjukdomar | Lungsjukdomar | Förmaksflimmer | Arytmier, hjärt | Hypertoni, lung