Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma

Conditions

newly diagnosed glioblastoma

Brief summary

The primary efficacy endpoint is OS measured from the day of surgery until death.

Detailed description

PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause., OS and PFS rates at 6, 12 and 24 months after the day of surgery., Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03., Overall and neurological performance as determined by the KPS and the MMSE-2., Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.

Related papers

No related papers found yet.

Interventions

DRUGAutologous

DRUGtumor lysate-loaded

DRUGmature dendritic cells vaccine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is OS measured from the day of surgery until death.	—

Secondary

Measure	Time frame
PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause., OS and PFS rates at 6, 12 and 24 months after the day of surgery., Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03., Overall and neurological performance as determined by the KPS and the MMSE-2., Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.	—

Measure

Time frame

PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause., OS and PFS rates at 6, 12 and 24 months after the day of surgery., Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03., Overall and neurological performance as determined by the KPS and the MMSE-2., Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.

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Countries

Germany

Outcome results

None listed