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Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection

2. september 2014 oppdatert av: Clinica Universidad de Navarra, Universidad de Navarra

Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope

  1. Primary outcome measure:

    a.Evaluation of the treatment impact on progression-free survival.

  2. Secondary outcome measures:

    1. Safety evaluation.

      • Direct effects attributable cell obtaining and administration.
      • Adverse events during treatment.
      • Neurological deterioration quantified using the NIH Stroke Scale.
      • Autoimmune phenomena.

    2. Evaluation of impact on other efficiency clinical parameters.

      • Overall survival.
      • Quality of life measured with EORTC questionnaire.

    3. Study of specific immune response and correlates with clinical outcome.

      • Delayed hypersensitivity.
      • Humoral response to autologous tumor cells/tumoral lysate.
      • Cellular response (proliferation, cytokine production, specific cytotoxicity).

    4. Cell line characterization and correlate the final product with clinical efficacy.

      • Phenotypic studies.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A prospective, open-label, unicentric phase II trial, historical control and non-randomized.

The study will try to evaluate the efficiency and safety of the experimental treatment using a cell therapy product (tumor lysate-pulsed autologous dendritic cell vaccine) in patients with glioblastoma multiforme in whom a gross total resection is feasible. Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.

Studietype

Intervensjonell

Registrering (Faktiske)

26

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Pamplona, Spania, 31008
        • Clinica Universidad de Navarra

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 til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with histological diagnosis of glioblastoma that have not received any previous chemotherapy or radiotherapy treatment.
  • Patients are able to give informed consent and willing to comply with the protocol requirements during the study period.
  • Age between 18 and 70 years
  • Negative pregnancy test In female fertile subjects
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Complete/Total resection of tumour with surgery guided by fluorescence microscopy and 5-aminolevulinic acid, observed with post operative magnetic resonance imaging. The residual lesion must be null or ≤ 1 cm3 by contrast capturing.
  • Enough tumor tissue available for the cellular vaccine elaboration

Exclusion Criteria:

  • Patients with infections, severe diseases or hepatic, renal or medullary failures, that in the investigator's opinion, are not eligible to participate in the study.
  • Participation in other clinical trial. If the patient has participated in other clinical trial within previous months, the patient has to complete the washout period required by de the investigator.
  • Patients with diagnosis of other neoplasia, except basal cell or squamous cell skin, carcinoma in situ of the cervix properly treated or other tumour curatively treated and no evidence of relapse for at least 3 years. Those cases with coexisting tumours of long-term survival prediction will be considered individually.
  • Pregnant or breast-feeding women.
  • Patients who need immunosuppressive drugs.
  • Positive serology for HIV , hepatitis B (HBsAg) or hepatitis C virus.
  • Impossible to get enough material for at least 6 cellular vaccine production.
  • Absolute contraindication for the patient to receive other steps of standard treatment of glioblastoma (surgery, radio and chemotherapy)

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Vaccination
Autologous Dendritic cells loaded with tumor lysate
Biologisk: autologous dendritic cells
Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Evaluation of the treatment impact on progression-free survival
Tidsramme: 5 years
5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety evaluation
Tidsramme: 5 years
  1. Direct effects attributable cell obtaining and administration
  2. Adverse events during treatment
  3. Neurological deterioration quantified using the NIH Stroke Scale
  4. Autoimmune phenomena
5 years
Evaluation of impact on other efficiency clinical parameters
Tidsramme: 5 years
  1. Overall survival
  2. Quality of life measured with EORTC questionnaire
5 years
Study of specific immune response and correlates with clinical outcome
Tidsramme: 5 years
  1. Delayed hypersensitivity
  2. Humoral response to autologous tumor cells/tumoral lysate
  3. Cellular response (proliferation, cytokine production, specific cytotoxicity)
5 years
Cell line characterization and correlate the final product with clinical efficacy
Tidsramme: 5 years
a. Phenotypic studies
5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Etterforskere

  • Studieleder: Felipe Prosper, MD, PhD, Clinica Universidad de Navarra

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.

Generelle publikasjoner

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. oktober 2009

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

30. oktober 2009

Først innsendt som oppfylte QC-kriteriene

30. oktober 2009

Først lagt ut (Anslag)

1. november 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DEND/GM
  • 2009-009879-35 (EudraCT-nummer)

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. .

Kliniske studier på Glioblastoma Multiforme

Kliniske studier på autologous dendritic cells

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