Clinical trial NCT02022384: Immunophenotyping From Blood of Patients With Malignant Gliomas
Official title: Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaplastic Astrocytoma
Glioblastoma Multiforme
Keywords: Malignant glioma
Anaplastic astrocytoma
Glioblastoma multiforme
Immune
Immunophenotyping
Immune cells
activation state
Quality of live
translational research
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with primary diagnosed glioblastoma multiforme or anaplastic astrocytoma

Brief summary: In this explorative study immunological changes during tumor therapy will be analyzed in patients with malignant glioma. Immunophenotyping before and during therapy is used as analysis method. Thereby immune cells are quantitatively and qualitatively detected from patient's blood at continuous time points. Additionally relevant mediators like cytokines, danger signals and chemokines are analyzed by other methods. Obtained results may give information about the effects of therapy on immunological processes and immune cells and may help to find immunological based predictive or prognostic tumor markers and to define time points for including additional immune therapy in the future.

Detailed description: Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.

Eligibility criteria: Inclusion Criteria:

* patients with glioblastoma or anaplastic astrocytoma
* legal age
* planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)

Exclusion Criteria:

* Fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German

Primary outcomes:
measure: immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Secondary outcomes:
measure: Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: documentation of medication
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: Acquisition of changes in imaging
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: Acquisition of life quality according to quality of life questionnaire (QLQ) (EORTC QLQ -BN20)
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: correlation of immunological parameters with clinical data
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: overall survival
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
measure: progression free survival
timeFrame: patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg
state: BAY
Study officials:
affiliation: Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Rainer Fietkau, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Udo S Gaipl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruhle PF, Goerig N, Wunderlich R, Fietkau R, Gaipl US, Strnad A, Frey B. Modulations in the Peripheral Immune System of Glioblastoma Patient Is Connected to Therapy and Tumor Progression-A Case Report from the IMMO-GLIO-01 Trial. Front Neurol. 2017 Jun 23;8:296. doi: 10.3389/fneur.2017.00296. eCollection 2017.