Valganciclovir for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment for individuals with brain metastases from breast cancer, specifically when the cytomegalovirus (CMV) is active. The trial evaluates the effectiveness and safety of Valganciclovir, an antiviral medication, in improving brain function and quality of life for these patients. Participants must have breast cancer that has spread to the brain and show signs of active CMV infection. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that Valganciclovir is likely to be safe for humans?
Research shows that Valganciclovir is generally safe for people. Studies have found that patients with glioblastoma, a type of brain cancer, can tolerate it well. One study added Valganciclovir to the usual treatment for these patients and found it to be safe. Another study supported these results, showing no major safety issues when Valganciclovir was used as an additional treatment. These studies suggest that Valganciclovir is likely safe for patients, but monitoring for any possible side effects during treatment remains important.12345
Why do researchers think this study treatment might be promising?
Valganciclovir is unique because it targets the human cytomegalovirus (HCMV) in brain cancer patients, which is not a typical focus of existing treatments. While most standard treatments for brain cancer involve surgery, radiation, or chemotherapy targeting tumor cells directly, Valganciclovir works differently by addressing viral components that might be influencing cancer progression. Researchers are excited about this approach because it introduces a new mechanism of action, potentially offering a complementary route to improve outcomes for patients with brain cancer.
What evidence suggests that Valganciclovir might be an effective treatment for brain cancer?
Research has shown that the drug valganciclovir, administered alongside standard-of-care treatment, may aid in treating certain brain cancers. In patients with glioblastoma, those who received valganciclovir with standard treatment lived longer on average—24.1 months compared to 13.3 months for those who did not receive it. Another study found that patients treated with valganciclovir had higher survival rates over two years. These findings suggest that valganciclovir might improve outcomes for patients with brain tumors linked to the reactivation of the cytomegalovirus (CMV).13678
Who Is on the Research Team?
Akshjot Puri, M.D.
Principal Investigator
The Houston Methodist Hospital Research Institute
Are You a Good Fit for This Trial?
Adults over 18 with breast cancer that has spread to the brain, showing progression despite previous treatments. Participants must have CMV infection (with specific blood test results) and be in a stable enough condition to give consent. They should not need ongoing blood transfusions and must have good kidney and liver function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Safety Lead-in
At least 10 patients will be enrolled to evaluate the safety of anti-HCMV therapy
Treatment
Anti-HCMV therapy with oral Valganciclovir at 900 mg twice a day for 2 weeks, followed by maintenance at 450 mg twice daily for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with quality-of-life and neurocognitive assessments
Long-term Follow-up
Participants will be followed for survival and adverse events for up to 2 months after treatment discontinuation
What Are the Treatments Tested in This Trial?
Interventions
- Valganciclovir
Trial Overview
The trial is testing Valganciclovir, an anti-CMV drug, alongside standard care for patients with reactivated CMV-infected brain metastases from breast cancer. It starts with a high dose for two weeks followed by a lower maintenance dose for four more weeks.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients. Anti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days). CMV PCR, IgG and IgM will be checked at the end of these four weeks. Patients will be followed with physical examinations and assessment of laboratory parameters as required per standard-of-care treatment. Quality-of-life, neurocognitive questionnaires, and MRI brain (if asymptomatic) every 2 months until subsequent intracranial progression or end of study, whichever comes first. Patients will be in follow-up for 24 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Citations
Valganciclovir as Add-on to Second-Line Therapy in Patients ...
Valganciclovir was well tolerated and seemed to improve survival after tumor recurrence in patients with recurrent disease both in re-operated and non-re- ...
2.
aacrjournals.org
aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-20-0369/77162/am/Valganciclovir-as-add-on-to-standard-therapy-inValganciclovir as add-on to standard therapy in glioblastoma ...
Results: Patients with newly diagnosed glioblastoma receiving valganciclovir had longer median survival (OS 24.1 vs 13.3 months, p<0.0001) and a 2-year ...
NCT04116411 | A Clinical Trial Evaluating the Efficacy of ...
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs ...
A Clinical Trial Evaluating the Efficacy of Valganciclovir ...
Progression free survival at 12 and 24 months, Tumor recurrence is estimated as clinical and radiological determination (RANO criteria and NANO criteria). The ...
5.
2minutemedicine.com
2minutemedicine.com/valganciclovir-treatment-associated-with-increased-survival-in-glioblastoma-multiforme/Valganciclovir treatment associated with increased survival ...
However, in follow-up study patients receiving valganciclovir did have a significantly increased 2-year survival compared to matched controls ( ...
6.
aacrjournals.org
aacrjournals.org/clincancerres/article/26/15/4031/82630/Valganciclovir-as-Add-on-to-Standard-Therapy-inValganciclovir as Add-on to Standard Therapy in Glioblastoma ...
Valganciclovir prolonged median OS of patients with newly diagnosed glioblastoma (with methylated or unmethylated MGMT promoter gene) and was safe to use.
Effects of valganciclovir as an add-on therapy in patients ...
A randomized, double-blind, placebo-controlled, hypothesis-generating study to examine the safety and potential efficacy of Valganciclovir as an add-on therapy ...
Effects of valganciclovir as an add‐on therapy in patients ...
Forty-two glioblastoma patients were randomized in double-blind fashion to receive Valganciclovir or placebo in addition to standard therapy for ...
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