Actively Recruiting
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
Led by The Methodist Hospital Research Institute · Updated on 2026-04-08
28
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Breast cancer with progressive brain metastases, with at least one lesion 2 cm or less in a noncritical brain area spared from radiation
- At least one untreated, progressive brain metastasis
- Serum HCMV DNA by PCR over 250 copies/ml or positive CMV IgG or IgM
- Able to give signed informed consent or have a legally authorized guardian provide consent
- Metastatic breast cancer with any systemic disease status (no evidence, remission, stable, or progressive)
- ECOG performance score of 0 to 2
- Adequate blood counts without ongoing transfusions (hemoglobin >9 g/dl, ANC >1500/mm3, platelets >100,000/mm3)
- Adequate kidney and liver function (creatinine clearance >60 mL/min, bilirubin ≤1.5 times upper limit, AST and ALT ≤2.5 times upper limit, serum albumin ≥3 g/dl)
- Other CMV treatments allowed if clinically indicated
- Postmenopausal status or negative pregnancy test for premenopausal women
- Women under 50 years old must be postmenopausal by defined hormonal or surgical criteria
- Women 50 years or older considered postmenopausal by amenorrhea or surgical history
- Willing and able to comply with study treatments, visits, and examinations including follow-up
You will not qualify if you...
- Single brain lesion that can be surgically removed
- Last intracranial progression-free survival greater than 12 months
- All progressive brain metastases have been treated with radiation
- Brain metastases requiring immediate intervention due to symptoms or location near vital brain structures, unless other untreated lesions are present
- Active pregnancy or breastfeeding
- Women of childbearing potential or fertile men unwilling to use effective contraception during and for three months after treatment
- Known psychiatric disorder interfering with study compliance
- Other malignancies within the past three years except non-melanoma skin cancer or carcinoma in situ of cervix
- Participation in another investigational clinical study within 28 days prior to study treatment
- Concurrent enrollment in other clinical studies unless observational or during follow-up
- Unresolved or unstable adverse events from prior investigational drugs
- Major surgery within 28 days prior to study treatment
- Non-English speakers due to neurocognitive test language requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Neal Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Milan Sheth
CONTACT
T
Titilayo Olubajo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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