Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma

Conditions

Glioblastoma grade IV

Brief summary

Overall survival (OS) and progression-free survival (PFS)

Detailed description

Feasibility will be assessed based on the number of (A) patients in the intention-to-treat (ITT) population that had a successful leukapheresis (B) patients in the ITT population that had production of qualified (phenotypic and functional requirements) vaccines (C) efficacy evaluable patients in the ITT population (D) patients with 3-weekly DC vaccine administration following chemoradiation and additional DC vaccination at day 21 of each maintenance chemotherapy cycle in the ITT population, Safety will be assessed based on adverse event frequency (scored according to the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events) in the safety population, Immunogenicity will be assessed based on ex vivo immune responses of all patients of the immunogenicity population

Related papers

No related papers found yet.

Interventions

DRUGWT1 LAMP mRNA DC

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) and progression-free survival (PFS)	—

Secondary

Measure	Time frame
Feasibility will be assessed based on the number of (A) patients in the intention-to-treat (ITT) population that had a successful leukapheresis (B) patients in the ITT population that had production of qualified (phenotypic and functional requirements) vaccines (C) efficacy evaluable patients in the ITT population (D) patients with 3-weekly DC vaccine administration following chemoradiation and additional DC vaccination at day 21 of each maintenance chemotherapy cycle in the ITT population, Safety will be assessed based on adverse event frequency (scored according to the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events) in the safety population, Immunogenicity will be assessed based on ex vivo immune responses of all patients of the immunogenicity population	—

Measure

Time frame

Feasibility will be assessed based on the number of (A) patients in the intention-to-treat (ITT) population that had a successful leukapheresis (B) patients in the ITT population that had production of qualified (phenotypic and functional requirements) vaccines (C) efficacy evaluable patients in the ITT population (D) patients with 3-weekly DC vaccine administration following chemoradiation and additional DC vaccination at day 21 of each maintenance chemotherapy cycle in the ITT population, Safety will be assessed based on adverse event frequency (scored according to the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events) in the safety population, Immunogenicity will be assessed based on ex vivo immune responses of all patients of the immunogenicity population

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Countries

Belgium

Outcome results

None listed