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New treatment option for Diffuse Intrinsic Pontine Glioma
Official title FUS Etoposide for DMG
ClinicalTrials.gov ID: NCT05762419
What this study is testing
What is Etoposide; Oral, 50 Mg?
Etoposide; Oral, 50 Mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diffuse intrinsic pontine glioma.
Also referred to as Etoposide phosphate.
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
- The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug to reach into the brain tumor.
- 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 4 to 21
You may be able to join if
- Ages 4 - 21 years
- Radiological diagnosis of Diffuse Midline Glioma with tumor involving the pons (intrinsic, pontine based infiltrative lesion; hypointense on T1...
- Lansky performance status score of at least 60 for people 16 years of age or younger.
- Karnofsky performance status of at least 60 for people greater than 16 years of age
- Organ Function:
You likely can't join if
- people that have previously received etoposide therapy
- people unable to tolerate study procedures and/or anesthesia based on the opinion of the principal investigator
- Uncontrolled seizure disorder
- Pregnancy or Breast-Feeding: pregnant or breast-feeding women will not be entered on this study, since there is yet no available information...
- Concomitant medications: people who are currently receiving another investigational drug or other anti-cancer agents are not eligible.
- Screening EKG with a QTc \> 450 msec.
See the full eligibility criteria
- Ages 4 - 21 years
- Radiological diagnosis of Diffuse Midline Glioma with tumor involving the pons (intrinsic, pontine based infiltrative lesion; hypointense on T1 weighted images (T1WIs) and hyperintense in T2 sequences, with mass effect...
- Lansky performance status score of at least 60 for people 16 years of age or younger.
- Karnofsky performance status of at least 60 for people greater than 16 years of age
- Organ Function:
- Adequate hematologic function defined as:
- Peripheral absolute neutrophil count ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Partial thromboplastin time (PTT) and activated partial thromboplastin time (APTT): within normal institutional limits
- Adequate renal function defined as:
- Potassium and magnesium levels within institutional limits
- Serum creatinine below the institutional upper limit of normal (ULN) for age and gender, or creatinine clearance: ≥ 60 mL/min/1.73m2
- Adequate hepatic function defined as:
- Total bilirubin below the institutional ULN for age
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × institutional ULN
- Prior Therapy:
- people must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment.
- Cytotoxic chemotherapy or anti-cancer agents known to be myelosuppressive: at least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy.
- Anti-cancer agents not known to be myelosuppressive: at least 7 days must have elapsed from last dose of agent.
- Antibodies: at least 21 days must have elapsed from infusion of last dose of antibody.
- Interleukins, interferons, and cytokines: at least 21 days must have elapsed since the completion of interleukins, interferon, or cytokines.
- Stem cell infusions: at least 42 days must have elapsed after completion of an autologous stem cell infusion, and at least 84 days must have elapsed after completion of an allogeneic stem cell infusion.
- Cellular therapy: at least 42 days must have elapsed since the completion of any type of cellular therapy
- Radiotherapy (XRT): at least 1 month must have elapsed after local XRT.
- people must be on a stable or decreasing dose of steroids, as well as stable dose of anti-seizure medication for at least 1 week.
- Subject able to give consent
- people that have previously received etoposide therapy
- people unable to tolerate study procedures and/or anesthesia based on the opinion of the principal investigator
- Uncontrolled seizure disorder
- Pregnancy or Breast-Feeding: pregnant or breast-feeding women will not be entered on this study, since there is yet no available information regarding human fetal or teratogenic toxicities; a pregnancy test must be...
- Concomitant medications: people who are currently receiving another investigational drug or other anti-cancer agents are not eligible.
- Screening EKG with a QTc \> 450 msec.
- people with evidence of active systemic infection
- people with a documented allergy to compounds of similar chemical or biologic composition to etoposide or gadolinium compounds
- people with implanted metallic or electrical devices
- people with uncontrollable hypertension
- people with a documented bleeding disorder
- people with history of structural cardiac anomalies or arrhythmias
- people with history of unprovoked stroke or signs of stroke in the area of FUS target
- people with SARS-CoV-2 infection requiring hospitalization in the past month and requires anticoagulation as per the Columbia University Irving Medical Center (CUIMC) institutional "Anticoagulation for COVID-19 Positive...
- people with coagulopathy or under anticoagulant therapy.
- people with signs of impending herniation or an acute or previous intratumoral hemorrhage
- people with spinal cord diffuse midline glioma
- people receiving a drug where CNS toxicity is reasonably suspected
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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, 4 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.