BridgeMD
New treatment option for Brain Cancer Metastatic
Official title Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
ClinicalTrials.gov ID: NCT07383649
What this study is testing
What is Valganciclovir?
Valganciclovir is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for brain cancer metastatic.
Also referred to as Valcyte.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female aged \>18 years at the time of consent
- Breast cancer with progressive brain metastases supra and/or infratentorial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm...
- At least one non irradiated, untreated progressive brain metastases site
- Serum HCMV DNA by real time PCR \> 250 copies/ml or positive CMV Ig G or Ig M.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in...
You likely can't join if
- Single resectable intracranial lesion
- Last intracranial progression free survival \> 12 months
- All progressive brain metastases have been radiated
- Brain metastases needing immediate local intervention such as mass effect, herniation, active neurological symptoms, increased intracranial pressure...
- Active pregnancy or breast feeding
- Women of childbearing potential or fertile men unwilling to use effective contraception (Section 6.2, Table 6) during study and up to three months...
See the full eligibility criteria
- Male or female aged \>18 years at the time of consent
- Breast cancer with progressive brain metastases supra and/or infratentorial. 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...
- At least one non irradiated, untreated progressive brain metastases site
- Serum HCMV DNA by real time PCR \> 250 copies/ml or positive CMV Ig G or Ig M.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. If the patient is unable to consent for any reason a...
- Metastatic breast cancer who has systemically no evidence of disease, complete remission, partial remission, stable or progressive disease
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- 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 x:≤1.5 upper limit of normal (ULN), aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≤ 2.5 x ULN and serum...
- Other CMV treatment if clinically indicated per physician's choice
- Evidence of postmenopausal status or negative serum pregnancy test for premenopausal female patients. Negative serum β-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment...
- Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
- Single resectable intracranial lesion
- Last intracranial progression free survival \> 12 months
- All progressive brain metastases have been radiated
- Brain metastases needing immediate local intervention such as mass effect, herniation, active neurological symptoms, increased intracranial pressure, those near vital structures like the motor cortex, proximity to the...
- Active pregnancy or breast feeding
- Women of childbearing potential or fertile men unwilling to use effective contraception (Section 6.2, Table 6) during study and up to three months after treatment discontinuation.
- Known psychiatric disorder that causes poor cooperation with the trial requirements.
- Participants with previous other malignancies must have had at least a 3-year disease free interval, except those with non-melanoma skin cancer or carcinoma in situ of cervix
- Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
- Concurrent enrollment in another clinical study unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment study.
- Unresolved or unstable adverse events (AEs) from prior administration of another investigational drug, per investigators' discretion.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
- Non-English-speaking people will not be enrolled in this study since the neurocognitive tests including DKEFS, RAVLT and TMT are not validated to be scored in other languages.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.