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Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection

NCT07383649 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-08

No results posted yet for this study

Summary

This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\> 250 copies/ml) or positive CMV IgG or IgM will be eligible to participate in the trial.

Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon/radiation oncologist. 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).

Conditions

  • Brain Cancer Metastatic
  • CMV Viremia

Interventions

DRUG

Valganciclovir

Valganciclovir inhibits viral DNA polymerase, effectively controlling HCMV reactivation and its associated immunosuppressive effects. Dosing for oral Valganciclovir will be based on standard of care dosing as per FDA in patients with HCMV infection. Dose adjustments will be made by the principal investigator for renal function, treatment-related AEs and disease progression according to the manufacturer's recommendations as they are present in individuals and will be assessed on a case-by-case basis.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Akshjot Puri, M.D. · The Houston Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07383649 on ClinicalTrials.gov