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Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

Primary Purpose

Glioblastoma Multiforme, Cytomegalovirus Infection

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Valganciclovir (Valcyte)

Placebo

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring glioblastoma multiforme, cytomegalovirus infection, antiviral treatment, valganciclovir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Glioblastoma grade IV
Cytomegalovirus detected in tumor
At least 90% resection of tumor

Exclusion Criteria:

Decreased kidney function
Pregnancy
Neutropenia
Thrombocytopenia
Patient not tolerating the drug

Sites / Locations

Department of neurosurgery, Karolinska University Hospital
Department of Oncology, Norrland University Hospital
Department of Oncology, Akademiska Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Valganciclovir

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Tumor size

Secondary Outcome Measures

Disease status

Patient survival

Full Information

NCT ID

NCT00400322

First Posted

November 15, 2006

Last Updated

February 25, 2021

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00400322

Brief Title

Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

Official Title

A Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 2006 (Actual)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme, Cytomegalovirus Infection

Keywords

glioblastoma multiforme, cytomegalovirus infection, antiviral treatment, valganciclovir

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valganciclovir

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Valganciclovir (Valcyte)

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Tumor size

Time Frame

Week twelve

Title

Tumor size

Time Frame

Week twenty four

Secondary Outcome Measure Information:

Title

Disease status

Time Frame

24 months

Title

Patient survival

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Glioblastoma grade IV Cytomegalovirus detected in tumor At least 90% resection of tumor Exclusion Criteria: Decreased kidney function Pregnancy Neutropenia Thrombocytopenia Patient not tolerating the drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inti Peredo, MD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cecilia Soderberg-Naucler, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Chair

Facility Information:

Facility Name

Department of neurosurgery, Karolinska University Hospital

City

Solna

State/Province

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Department of Oncology, Norrland University Hospital

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Department of Oncology, Akademiska Hospital

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

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