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Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma

26. maj 2017 opdateret af: Benjamin Purow, MD, University of Virginia

A Pilot Study to Evaluate the Feasibility of the Combined Use of Stereotactic Radiosurgery With Nivolumab and Concurrent Valproate in Patients With Recurrent Glioblastoma

The purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Immune checkpoint inhibitors have the potential to treat a wide range of diverse cancers. Of particular interest to researchers is the PD-1 receptor-ligand interaction, a major pathway that many cancers hijack in order to suppress immune control. Anti-PD-1 antibodies such as nivolumab show a strong potential to treat many types of cancers including glioblastoma, the most common and most lethal brain cancer.

This study will examine a means of further focusing immune response on glioblastoma by combining stereotactic "gamma knife" radiosurgery with nivolumab. The rationale behind this intervention is that the radiation therapy will enhance immune response rate by providing additional tumor antigens from dying cells. Additionally, a study from investigators at Johns Hopkins indicates that histone deacetylase (HDAC) inhibitors may boost the anti-cancer efficacy of PD-1 antibodies like nivolumab. Valproate, a class I HDAC inhibitor, will be used concurrently with nivolumab with the goal of enhancing the effects of both the nivolumab and the radiotherapy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Confirmed malignant, recurrent glioblastoma or gliosarcoma
  • Subject must have adequate organ function
  • Subject must still be able to care for most of his or her personal needs

Exclusion Criteria:

  • Subject is pregnant
  • Subject has extracranial metastatic or leptomeningeal disease
  • Subject has an additional malignancy that is progressing or requires active treatment, exceptions being basal cell and squamous cell carcinomas of the skin, indolent prostate cancer, chronic lymphocytic leukemia, or in situ cervical cancer
  • Subject has received chemotherapy, biological therapy, or had surgery 4 weeks prior to beginning the study
  • Subject has had radiation therapy within 10 weeks prior to entering beginning the study
  • Subject has had prior therapy with bevacizumab
  • Subject has had previous treatment with carmustine wafer except when administered as first-line treatment no less than six months prior to beginning the study
  • Subject requires escalating supraphysiologic doses of corticosteroids greater than 2 mg of dexamethasone or an equivalent
  • Active autoimmune disease requiring systemic treatment within the past 3 months or any syndrome that requires immunosuppressive agents
  • Interstitial lung disease or active, non-infectious pneumonitis
  • Evidence of greater than Grade 1 CNS hemorrhage or greater than Grade 3 venous thromboembolism
  • History of uncontrolled cardiac disease
  • Subject unable or unwilling to have a head contrast enhanced MRI

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nivolumab & Valproate Following G.K.
Subjects will begin a valproate regimen prior to undergoing stereotactic radiosurgery (gamma knife) on a single lesion. Following the surgery, subjects will receive nivolumab every 2 weeks and daily valproate.
Stråling: Stereotactic Radiosurgery
Subjects will receive a single large dose of radiation to one or more lesions.
Andre navne:
  • Gamma Knife Radiosurgery
Medicin: Nivolumab
3 mg/kg of nivolumab will be administered through IV infusion every two weeks following stereotactic radiosurgery.
Andre navne:
  • Opdivo
Medicin: Valproate
Subjects will begin regimen of valproate prior to radiosurgery and continue to receive therapy concurrently with nivolumab. Subjects will receive valproate daily with a target serum level of 75-100 μg/ml.
Andre navne:
  • Natriumvalproat
  • Valproinsyre
  • Divalproex Sodium

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility based on number of subjects who complete 4 doses of nivolumab
Tidsramme: At 3 months following radiosurgery
Feasibility of the radiosurgery and drug combination will be determined based on the number of subjects who complete at least 4 doses of nivolumab.
At 3 months following radiosurgery
Incidence of adverse events
Tidsramme: From the beginning of treatment until no sooner than 30 days following the last study treatment
Safety will be assessed by imaging of necrosis, incidence and severity of adverse events, changes in laboratory findings, physical examinations, vital signs, and the number of discontinuations due to adverse events.
From the beginning of treatment until no sooner than 30 days following the last study treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Response Rate
Tidsramme: From the beginning of treatment until documented disease progression or date of death, assessed up to 48 months.
Response to therapy will be evaluated by means of RANO criteria.
From the beginning of treatment until documented disease progression or date of death, assessed up to 48 months.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Pseudoprogressions
Tidsramme: From the beginning of treatment until documented disease progression or date of death, assessed up to 48 months.
Pseudoprogression, the transient increase in apparent tumor size, will be documented.
From the beginning of treatment until documented disease progression or date of death, assessed up to 48 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Virginia

Efterforskere

  • Ledende efterforsker: Benjamin Purow, MD, University of Virginia

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 (Faktiske)

24. maj 2016

Primær færdiggørelse (Faktiske)

21. februar 2017

Studieafslutning (Faktiske)

21. februar 2017

Datoer for studieregistrering

Først indsendt

16. december 2015

Først indsendt, der opfyldte QC-kriterier

6. januar 2016

Først opslået (Skøn)

7. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18574
  • CA209-378 (Anden identifikator: University of Virginia)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Glioblastom

Kliniske forsøg med Stereotactic Radiosurgery

Søg i lignende forsøg

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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