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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002022-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valganciclovir (Valcyte) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor size | Week twelve | |
| Tumor size | Week twenty four |
| Measure | Description | Time Frame |
|---|---|---|
| Disease status | 24 months | |
| Patient survival | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inti Peredo, MD | Karolinska University Hospital | Principal Investigator |
| Cecilia Soderberg-Naucler, MD, PhD | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurosurgery, Karolinska University Hospital | Solna | Stockholm County | 17176 | Sweden | ||
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|
| Department of Oncology, Norrland University Hospital |
| Umeå |
| 901 85 |
| Sweden |
| Department of Oncology, Akademiska Hospital | Uppsala | 751 85 | Sweden |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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