BridgeMD
Tests treatment safety and results for Recurrent High Grade Glioma
Official title Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252
ClinicalTrials.gov ID: NCT06126744
What this study is testing
What is MVR-C5252?
MVR-C5252 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent high grade glioma.
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 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.
- Phase 1: an early, usually small safety study
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
- Age \>18 years of age
- Disease recurrence of at least 1x1cm and a maximum of 3x3cm of enhancing tumor: Dose escalation portion: patients with recurrent high-grade glioma...
- The neurosurgeon must confirm (a) the tumor location (\> 1 cm from eloquent brain), (b) that the placement of infusion catheter within or through the...
- Within the enhancing portion or in the vicinity of enhancement of target lesion (i.e., infiltrative disease)
- ≥ 0.5 cm from ventricles
You likely can't join if
- Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or...
- Patients who are pregnant or breastfeeding
- Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, tumor in eloquent brain regions, extensive tumor...
- Unstable systemic disease in the opinion of the treating physician.
- Active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or people with unexplained fever (temperature \> 38.1˚C) within...
- Patients on \>4 mg per day of dexamethasone within the 2 weeks prior to admission for MVR-C5252 infusion or systemic therapy with immunosuppressive...
See the full eligibility criteria
- Age \>18 years of age
- Disease recurrence of at least 1x1cm and a maximum of 3x3cm of enhancing tumor: Dose escalation portion: patients with recurrent high-grade glioma, IDH wt or IDH mutated, grade 3 or grade 4 based on imaging. Dose...
- The neurosurgeon must confirm (a) the tumor location (\> 1 cm from eloquent brain), (b) that the placement of infusion catheter within or through the progressive enhancing tumor is feasible and is at a safe distance to...
- Within the enhancing portion or in the vicinity of enhancement of target lesion (i.e., infiltrative disease)
- ≥ 0.5 cm from ventricles
- ≥ 1 cm deep into the brain
- ≥ 0.5 cm from the corpus callosum
- If a histological or pathological confirmation of recurrence (\< 6 weeks) is not available, a pre-infusion biopsy will be required to confirm recurrence.
- Adequate pulmonary function, with a baseline pulse oximetry of at 90% on room air.
- The subject must have received standard radiation therapy plus temozolomide and be refractory to radiation therapy plus temozolomide prior to enrollment.
- Prior to administration of MVR-C5252, the presence of recurrent tumor must be confirmed by histopathological analysis. (Distinguishing between recurrent active tumor and radiation necrosis is important to avoid...
- Karnofsky Performance Status (KPS) ≥ 70%
- Labs:
- platelets ≥ 100,000 unsupported at initial screening, but ≥ 125,000 supported prior to biopsy/catheter insertion
- hemoglobin ≥ 9 gm/dL, ANC ≥ 1000/µL
- creatinine ≤ 1.5x upper limit of normal (ULN)
- total bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN (people with known or suspected Gilbert's syndrome are excluded if total bilirubin \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN)
- PT, aPTT ≤ 1.2 x ULN prior to biopsy (if patient is taking warfarin, INR should be obtained and be \< 2.0)
- Able to undergo MRI brain with and without contrast
- If the patient is a sexually active female of childbearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of child bearing potential, the patient must use...
- Signed informed consent approved by the Institutional Review Board
- Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- Patients who are pregnant or breastfeeding
- Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, tumor in eloquent brain regions, extensive tumor dissemination (subependymal or leptomeningeal), or in unsafe brain...
- Unstable systemic disease in the opinion of the treating physician.
- Active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or people with unexplained fever (temperature \> 38.1˚C) within 7 days prior to the day of investigational product administration.
- Patients on \>4 mg per day of dexamethasone within the 2 weeks prior to admission for MVR-C5252 infusion or systemic therapy with immunosuppressive agents within 28 days prior to admission for MVR-C5252 infusion
- Patients who have not completed standard of care treatment prior to participation in this trial
- Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation of recurrent tumor
- Treated with immunotherapeutic agents prior to MVR-C5252 treatment, within 4 weeks, alkylating agents within 4 weeks, nitrosoureas within 6 weeks, or non-alkylating chemotherapy within 2 weeks before enrollment, unless...
- Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy
- Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period
- Prior treatment with any oncolytic virus, cell therapy or gene therapy.
- Prior antitumor treatment with intracranial implants, such as Carmustine
- Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the MVR-C5252 prescription, including glycerol.
- Systemic use (other than topical) of anti-HSV drugs (including, but not limited to, acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir, etc.)
- Patients with cardiac risks including congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 New York, New York, United States; Durham, North Carolina, 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.