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 (May 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
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
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