Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
3. januar 2019 opdateret af: Robert Schoen
Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring.
MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma.
The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1.
Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps.
Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination.
Vaccine will be administered at weeks 0, 2, and 10.
Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase.
However, all subjects will be administered the vaccine, regardless of baseline antibody status.
To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Digestive Disorders Clinic
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
- Colorectal adenoma(s) ≥ 1 cm in maximal diameter
- Colorectal adenoma(s) with villous or tubulovillous histology
- Colorectal adenoma(s) with high-grade dysplasia
- Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
- ECOG performance status 0 or 1
- Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets ≥100,000/µL.
- AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine ≤ 1.5x upper limit of institutional normal.
- ANA < 1:160
Exclusion Criteria:
- Receiving any other investigational agents.
- Presence of an active acute or chronic infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
- History of heritable cancer syndrome (FAP, HNPCC)
- Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- History of malignancy < 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
- Any use of oral corticosteroids ≤ 12 weeks prior to Registration/Randomization.
- Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
- Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MUC1 Poly-ICLC
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The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic.
The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh.
The site of injection will remain the same thigh, to enhance the potential immune response.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Anti Muc-1 Antibody
Tidsramme: 52 weeks
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Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
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52 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Autoimmune Response to Muc-1 Vaccine
Tidsramme: 52 weeks
|
Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
|
52 weeks
|
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Number of Participants With Adverse Events Associated With the Study Agent
Tidsramme: 54 weeks
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Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
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54 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert E Schoen, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2008
Primær færdiggørelse (Faktiske)
1. oktober 2011
Studieafslutning (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først indsendt
15. oktober 2008
Først indsendt, der opfyldte QC-kriterier
15. oktober 2008
Først opslået (Skøn)
16. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Adenom
- Lægemidlers fysiologiske virkninger
- Immunologiske faktorer
- Interferon-inducere
- Poly ICLC
Andre undersøgelses-id-numre
- PRO07030214
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .