Immunophenotyping From Blood of Patients With Malignant Gliomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy

Conditions
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Anaplastic Astrocytoma, Glioblastoma Multiforme

Intervention / Treatment
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* Other: Blood sample and life quality questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study patients<br>Blood sample and life quality questionnaires | Other: Blood sample and life quality questionnaires<br>* Blood will be drawn at distinct time points during and after radio(chemo)therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood | Time points for blood sample collections: Before start of chemoradiation (RCT). In 3th week of RCT. At last day of RCT. At the beginning of chemotherapy (CT) (about 4 weeks after RCT). During CT each three to four weeks. At follow-up visits each one to three months. During recurrence therapy. | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| documentation of medication |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| Acquisition of changes in imaging |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| Acquisition of life quality according to quality of life questionnaire (QLQ) (EORTC QLQ -BN20) |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| correlation of immunological parameters with clinical data | Correlation with results of immunophenotyping, possibly definition of medically relevant markers | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| overall survival |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 
| progression free survival |  | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant glioma, Anaplastic astrocytoma, Glioblastoma multiforme, Immune, Immunophenotyping, Immune cells, activation state, Quality of live, translational research