OncoMatch/Clinical Trials/NCT07383649
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
Is NCT07383649 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Valganciclovir for brain cancer metastatic.
Treatment: Valganciclovir — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
hemoglobin > 9 g/dl, ANC > 1500 per mm3, platelets > 100,000 per mm3, without ongoing transfusion support
Kidney function
creatinine clearance [CrCL] > 60 mL/min
Liver function
bilirubin ≤1.5 ULN, AST and ALT ≤ 2.5 x ULN, serum albumin ≥ 3 g/dl
Adequate hematology without ongoing transfusion support (hemoglobin > 9 g/dl, absolute neutrophil count (ANC) > 1500 per mm3 , platelets > 100,000 per mm3). Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin ≤1.5 ULN, AST and ALT ≤ 2.5 x ULN and serum albumin ≥ 3 g/dl).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Methodist Neal Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07383649 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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