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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme, Cytomegalovirus Infection

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Tumor size

Outcome Time Frame:

week twelve and week twenty four

Principal Investigator

Inti Peredo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska University Hospital

Authority:

Sweden: Medical Products Agency

Study ID:

MV20145

NCT ID:

NCT00400322

Start Date:

August 2006

Completion Date:

March 2009

Related Keywords:

  • Glioblastoma Multiforme
  • Cytomegalovirus Infection
  • glioblastoma multiforme
  • cytomegalovirus infection
  • antiviral treatment
  • valganciclovir
  • Cytomegalovirus Infections
  • Glioblastoma

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