A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
NCT04116411 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2025-12-22
Summary
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.
Conditions
Interventions
- DRUG
-
Valganciclovir Tablets
Valganciclovir treatment of glioblastoma
- DRUG
-
Temozolomide 120 mg
Chemotherapy
- RADIATION
-
Radiotherapy 60 Gy
Radiation therapy
- DRUG
-
Placebo oral tablet
Placebo treatment of glioblastoma
Sponsors & Collaborators
-
Karolinska University Hospital
collaborator OTHER - collaborator OTHER
-
Cecilia Soderberg-Naucler
lead OTHER
Principal Investigators
-
Giuseppe Stragliotto, MD, PhD · Karolinska University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-04
- Primary Completion
- 2027-09-16
- Completion
- 2027-09-16
Countries
- Norway
- Sweden
Study Locations
More Related Trials
-
Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors
NCT06914479 ·Status: RECRUITING ·Phase: PHASE1
-
Clinical Study of Oncolytic Virus in Glioblastoma
NCT07145047 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
NCT00005637 ·Status: COMPLETED ·Phase: PHASE1
-
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
NCT03603405 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00128700 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
NCT00003417 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
NCT05083754 ·Status: RECRUITING ·Phase: PHASE1
-
Glutamate Inhibitors in Glioblastoma
NCT05664464 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Hyperpolarized Imaging in Diagnosing Participants With Glioma
NCT03739411 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma
NCT05938387 ·Status: COMPLETED ·Phase: PHASE1
-
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
NCT00006386 ·Status: COMPLETED ·Phase: PHASE2
-
Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
NCT00005081 ·Status: COMPLETED ·Phase: PHASE2
-
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00869401 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00003996 ·Status: COMPLETED ·Phase: PHASE2
-
G207 Followed by Radiation Therapy in Malignant Glioma
NCT00157703 ·Status: COMPLETED ·Phase: PHASE1
-
Carmustine Plus O(6)-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain
NCT00003348 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
NCT03970447 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2
NCT03152318 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
NCT00046878 ·Status: WITHDRAWN ·Phase: PHASE2
-
Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy
NCT01430351 ·Status: TERMINATED ·Phase: PHASE1
-
Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT02337426 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
NCT01878617 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS
NCT04810182 ·Status: COMPLETED
-
Trial of C134 in Patients With Recurrent GBM
NCT03657576 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Bevacizumab With or Without Surgery for Adult Glioblastomas
NCT01413438 ·Status: WITHDRAWN ·Phase: PHASE2