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

Cytomegalovirus Infections Clinical Trial

— GLIO-CMV-01  

Official title:

Analysis of CMV Infections in Patients Suffering From Brain Tumors and Brain Metastases During and After Radio(Chemo)Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600065
• Other study ID #: GLIO-CMV-01
• Status: Completed
• Start date: November 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Communicable Diseases
• Cytomegalovirus Infections
• Infections

Intervention

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.

Locations

Country	Name	City	State
Germany	Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of CMV status during radio(chemo)therapy (RCT)	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.	up to day 45 after start of Radiotherapy
Secondary	Change of circulating immune cells of treated patients by deep immunophenotyping.	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.	up to month 6 after the start of Radiotherapy