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Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy (GLIO-CMV-01)

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ClinicalTrials.gov Identifier: NCT02600065
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.

Condition or disease Intervention/treatment
Cytomegalovirus Infections Other: Blood draw and MRI

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of CMV Infections in Patients Suffering From Brain Tumors and Brain Metastases During and After Radio(Chemo)Therapy
Study Start Date : November 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 30, 2019


Group/Cohort Intervention/treatment
Study cohort

All patients who are suffering from brain tumor of brain metastases and are willing to participate.

The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.

Other: Blood draw and MRI
The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.




Primary Outcome Measures :
  1. Change of CMV status during radio(chemo)therapy (RCT) [ Time Frame: up to day 45 after start of Radiotherapy ]
    CMV infection will be monitored by virus analysis by an approved laboratory. The analyses were conducted at time points during and after RCT - before RT (day 0), during RT (dose halftime), end of RT (last day of RT), month 3 and 6 after completed RT. This scheme is repeated if patient receives additional RT for relapse treatment. The time points during RT were determined depending on the applied irradiation dose. For glioblastoma the halftime of RT is usually day 23 (received dose 30 Gy) and the end of therapy is usually day 45 (received dose 60 Gy). For cerebral metastases the halftime of the RT is usually day 8 (received dose 9 Gy) and day 16 at the end of therapy (received dose 18 Gy). However, the time points are strongly connected to the received dose.


Secondary Outcome Measures :
  1. Change of circulating immune cells of treated patients by deep immunophenotyping. [ Time Frame: up to month 6 after the start of Radiotherapy ]
    Immunophenotyping of the patients. Detection of about 30 distinct immune sell (sub)types together with their activation markers.The analyses were conducted at time points during and after RCT - before RT (day 0), during RT (dose halftime), end of RT (last day of RT), month 3 and 6 after completed RT. This scheme is repeated if patient receives additional RT for relapse treatment. The time points during RT were determined depending on the applied irradiation dose. For glioblastoma the halftime of RT is usually day 23 (received dose 30 Gy) and the end of therapy is usually day 45 (received dose 60 Gy). For cerebral metastases the halftime of the RT is usually day 8 (received dose 9 Gy) and day 16 at the end of therapy (received dose 18 Gy). However, the time points are strongly connected to the received dose.


Biospecimen Retention:   Samples Without DNA
blood for CMV status analysis blood for immunophenotyping serum plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain tumours (glioblastoma or anaplastic astrocytoma Patients with brain metastases from diagnosed primary tumours
Criteria

Inclusion Criteria:

  • brain tumours (glioblastoma or anaplastic astrocytoma)
  • brain metastases from diagnosed primary tumours
  • legal age
  • planned chemoradiation and adjuvant chemotherapy [metastases]
  • planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et. al.) [brain tumors]

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
  • patients with claustrophobia
  • patients with artificial joint or any metal parts in the body
  • patients with pacemakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600065


Contacts
Contact: Benjamin Frey, Dr. +49 9131 85 44248 benjamin.frey@uk-erlangen.de
Contact: Marga Lang-Welzenbach, M.A. +49 9131 85 33968 marga.lang-welzenbach@uk-erlangen.de

Locations
Germany
Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Rainer Fietkau, Prof.    +49 9131 85 33405    rainer.fietkau@uk-erlangen.de   
Contact: Udo S Gaipl, Prof.    +49 9131 85 44258    udo.gaipl@uk-erlangen.de   
Sub-Investigator: Benjamin Frey, Dr.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Rainer Fietkau, Prof. Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02600065     History of Changes
Other Study ID Numbers: GLIO-CMV-01
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cytomegalovirus Infections
Infection
Communicable Diseases
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases