Efficacy and Safety of Valcyte® as an Add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Karolinska University Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Karolinska University Hospital
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00400322
First received: November 15, 2006
Last updated: January 21, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glioblastoma Multiforme Cytomegalovirus Infection |
Drug: Valganciclovir (Valcyte) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Cytomegalovirus Infections
Drug Information available for:
Valganciclovir hydrochloride
Genetic and Rare Diseases Information Center resources:
Anaplastic Astrocytoma
Cytomegalic Inclusion Disease
Glioblastoma
Glioma
Gliosarcoma
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Karolinska University Hospital:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400322
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400322
Locations
| 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 | |
Sponsors and Collaborators
Karolinska University Hospital
Investigators
| Principal Investigator: | Inti Peredo, MD | Karolinska University Hospital | |
| Study Chair: | Cecilia Soderberg-Naucler, MD, PhD | Karolinska Institutet |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00400322 History of Changes |
| Other Study ID Numbers: | MV20145, Eudra CT: 2006-002022-29 |
| Study First Received: | November 15, 2006 |
| Last Updated: | January 21, 2009 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska University Hospital:
|
glioblastoma multiforme cytomegalovirus infection antiviral treatment valganciclovir |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Glioblastoma Astrocytoma DNA Virus Infections Glioma Herpesviridae Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Virus Diseases Valganciclovir Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015