Valganciclovir for Brain Cancer

MS
TO
Overseen ByTitilayo Olubajo
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
Must be taking: Anti-HCMV therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

AP

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

My breast cancer has spread to my brain, but I can have targeted radiation as long as one small lesion is left untreated.
I have at least one brain metastasis that hasn't been treated or irradiated.
4. Serum HCMV DNA by real time PCR \> 250 copies/ml or positive CMV Ig G or Ig M.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Safety Lead-in

At least 10 patients will be enrolled to evaluate the safety of anti-HCMV therapy

6 weeks

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

6 weeks
Weekly labs for viral clearance and toxicity monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with quality-of-life and neurocognitive assessments

24 months
Every 2 months MRI and assessments

Long-term Follow-up

Participants will be followed for survival and adverse events for up to 2 months after treatment discontinuation

2 months

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

Group I: Anti-HCMV therapy (Oral Valganciclovir) and Standard-of-CareExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

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- ...

Valganciclovir 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 ...

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 ( ...

Valganciclovir 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.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23404447/

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 ...