Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07383649

Initial Safety Lead-in Followed by Phase II Trial of Anti-HCMV Therapy with Valganciclovir in Breast Cancer Patients with Progressive Brain Metastases and CMV Infection

Led by The Methodist Hospital Research Institute · Updated on 2026-04-08

28

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, impact on brain function, and quality of life of anti-cytomegalovirus (CMV) therapy combined with standard care in patients who have breast cancer that has spread to the brain and shows active CMV infection. This phase II trial includes an initial safety phase with at least 10 patients, followed by a larger phase with 18 patients. The study focuses on adults aged 18 years or older who have progressive brain metastases and evidence of CMV activity in their blood. Participants receive oral Valganciclovir, an anti-CMV drug, starting with a higher dose of 900 mg twice daily for 2 weeks. After this induction period, the dose is lowered to 450 mg twice daily for an additional 4 weeks. Patients may also undergo stereotactic radiosurgery (SRS) if at least one small brain lesion (2 cm or less) in a noncritical brain area can be spared, based on specialist evaluation. The study includes monitoring of CMV levels and safety labs during treatment, with ongoing follow-up for 24 months. During the trial, patients will have regular blood tests to track viral clearance and check for side effects. Pill counts will monitor medication adherence. Brain MRI scans and cognitive tests will be done every two months or when symptoms appear to assess tumor response and brain function. Quality-of-life questionnaires will also be collected. Adverse events will be tracked for two months after treatment, with survival monitored for up to two years following the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older at the time of consent
  • Breast cancer with progressive brain metastases, including supra- or infratentorial areas
  • At least one untreated, non-irradiated progressive brain metastasis
  • Serum HCMV DNA greater than 250 copies/ml by PCR or positive CMV IgG or IgM
  • Ability to give signed informed consent or have a legally authorized guardian provide consent
  • Metastatic breast cancer with systemic disease status of remission, stable, or progressive
  • Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 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 treatment allowed if clinically indicated
  • Postmenopausal status or negative pregnancy test for premenopausal women
  • Women under 50 considered postmenopausal if amenorrheic 12 months or more and with specific hormone levels or surgical sterilization
  • Women 50 or older considered postmenopausal if amenorrheic 12 months or more, or with treatment-induced menopause or surgical sterilization
  • Willingness and ability to comply with treatment and scheduled visits
Not Eligible

You will not qualify if you...

  • Single resectable brain lesion
  • Intracranial progression-free survival longer than 12 months
  • All progressive brain metastases have been previously radiated
  • Brain metastases requiring immediate intervention due to mass effect, herniation, or symptoms near vital brain areas unless other non-radiated lesions exist
  • Active pregnancy or breastfeeding
  • Women of childbearing potential or fertile men unwilling to use contraception during and up to three months after treatment
  • Known psychiatric disorder causing poor trial cooperation
  • History of other cancers unless disease-free for at least 3 years, except certain skin and cervical cancers
  • Participation in another investigational drug trial within 28 days before starting treatment
  • Concurrent enrollment in another clinical interventional study unless observational or in follow-up
  • Unresolved or unstable adverse events from prior investigational drugs
  • Major surgery within 28 days before starting treatment
  • Non-English speakers due to neurocognitive test limitations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment - Induction

Duration - 2 weeks

Participants receive oral Valganciclovir at 900 mg twice a day to control HCMV reactivation alongside standard-of-care treatment.

Weekly visits for labs monitoring viral clearance, toxicity, and electrolyte levels

Treatment - Maintenance

Duration - 4 weeks

Participants continue oral Valganciclovir at 450 mg twice daily to maintain viral suppression alongside standard-of-care treatment.

Every 2 weekly visits for labs assessing toxicity and electrolytes, with pill counting for compliance

Follow-up

Duration - Up to 24 months

Participants are monitored for quality-of-life, neurocognitive function, and tumor status with MRI brain scans every 2 months until intracranial progression or end of study. Physical examinations and lab assessments occur as required per standard-of-care.

MRI brain every 2 months if asymptomatic; additional MRIs at symptom onset; neurocognitive testing every 8 weeks

Trial Site Locations

Total: 1 location

1

Houston Methodist Neal Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Milan Sheth

T

Titilayo Olubajo

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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