Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection
2 september 2014 bijgewerkt door: 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
Primary outcome measure:
a.Evaluation of the treatment impact on progression-free survival.
Secondary outcome measures:
Safety evaluation.
- Direct effects attributable cell obtaining and administration.
- Adverse events during treatment.
- Neurological deterioration quantified using the NIH Stroke Scale.
- Autoimmune phenomena.
Evaluation of impact on other efficiency clinical parameters.
- Overall survival.
- Quality of life measured with EORTC questionnaire.
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).
Cell line characterization and correlate the final product with clinical efficacy.
- Phenotypic studies.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
26
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pamplona, Spanje, 31008
- Clinica Universidad de Navarra
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Vaccination
Autologous Dendritic cells loaded with tumor lysate
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Evaluation of the treatment impact on progression-free survival
Tijdsspanne: 5 years
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5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Safety evaluation
Tijdsspanne: 5 years
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5 years
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Evaluation of impact on other efficiency clinical parameters
Tijdsspanne: 5 years
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5 years
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Study of specific immune response and correlates with clinical outcome
Tijdsspanne: 5 years
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5 years
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Cell line characterization and correlate the final product with clinical efficacy
Tijdsspanne: 5 years
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a. Phenotypic studies
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5 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Felipe Prosper, MD, PhD, Clinica Universidad de Navarra
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24. doi: 10.3171/jns.1999.90.6.1115.
- Omuro AM, Faivre S, Raymond E. Lessons learned in the development of targeted therapy for malignant gliomas. Mol Cancer Ther. 2007 Jul;6(7):1909-19. doi: 10.1158/1535-7163.MCT-07-0047.
- Inoges S, Tejada S, de Cerio AL, Gallego Perez-Larraya J, Espinos J, Idoate MA, Dominguez PD, de Eulate RG, Aristu J, Bendandi M, Pastor F, Alonso M, Andreu E, Cardoso FP, Valle RD. A phase II trial of autologous dendritic cell vaccination and radiochemotherapy following fluorescence-guided surgery in newly diagnosed glioblastoma patients. J Transl Med. 2017 May 12;15(1):104. doi: 10.1186/s12967-017-1202-z.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2009
Primaire voltooiing (Werkelijk)
1 augustus 2014
Studie voltooiing (Werkelijk)
1 augustus 2014
Studieregistratiedata
Eerst ingediend
30 oktober 2009
Eerst ingediend dat voldeed aan de QC-criteria
30 oktober 2009
Eerst geplaatst (Schatting)
1 november 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
3 september 2014
Laatste update ingediend die voldeed aan QC-criteria
2 september 2014
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DEND/GM
- 2009-009879-35 (EudraCT-nummer)
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