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Immunophenotyping From Blood of Patients With Malignant Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02022384
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Erlangen-Nürnberg Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rainer Fietkau, Prof.Udo S Gaipl, Prof.
Principal Investigator Affiliation Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anaplastic Astrocytoma, Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

: study patients

Blood sample and life quality questionnaires

Interventions

Other: - Blood sample and life quality questionnaires

Blood will be drawn at distinct time points during and after radio(chemo)therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Erlangen, BAY, Germany

Status

Address

Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg

Erlangen, BAY, 91054