Efficacy and Safety of Valcyte® as an Add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
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ClinicalTrials.gov Identifier: NCT00400322 |
Recruitment Status : Unknown
Verified January 2009 by Karolinska University Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2006
Last Update Posted : January 22, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme Cytomegalovirus Infection | Drug: Valganciclovir (Valcyte) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | August 2006 |
Estimated Study Completion Date : | March 2009 |

- Tumor size [ Time Frame: week twelve and week twenty four ]
- Disease status
- Patient survival

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00400322
Sweden | |
Department of neurosurgery, Karolinska University Hospital | |
Solna, Stockholm, Sweden, 17176 | |
Department of Oncology, Norrland University Hospital | |
Umea, Sweden, 901 85 | |
Department of Oncology, Akademiska Hospital | |
Uppsala, Sweden, 751 85 |
Principal Investigator: | Inti Peredo, MD | Karolinska University Hospital | |
Study Chair: | Cecilia Soderberg-Naucler, MD, PhD | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00400322 History of Changes |
Other Study ID Numbers: |
MV20145 Eudra CT: 2006-002022-29 |
First Posted: | November 16, 2006 Key Record Dates |
Last Update Posted: | January 22, 2009 |
Last Verified: | January 2009 |
glioblastoma multiforme cytomegalovirus infection antiviral treatment valganciclovir |
Infection Communicable Diseases Cytomegalovirus Infections Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir Antiviral Agents Anti-Infective Agents |