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New treatment option for High Grade Glioma
Official title Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors
ClinicalTrials.gov ID: NCT07424092
What this study is testing
What is DNX-2401?
DNX-2401 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and...
- Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors [medulloblastomas, ATRT, EMTR...
- Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecutive MRI or if they occur at least...
- Male and female participants age ≥ 1 years and ≤ 25 years.
- A single measurable lesion longer than 10 mm in two perpendicular diameters, considered by the investigator to be accessible for safe stereotactic...
You likely can't join if
- Any medical or psychological condition or disease that might interfere with the subject's ability to participate or give informed consent (if older...
- Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system.
- Any treatment outside the allowable guidelines outlined in the inclusion criteria.
- Severe acute infection or intercurrent medical condition including, but not limited to se-vere renal, hepatic, heart or bone marrow failure that...
- people with immunodeficiency or autoimmune conditions, active hepatitis or known HIV. No testing for Hepatitis B, Hepatitis C and HIV is required...
- people with another primary malignancy.
See the full eligibility criteria
- The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides writ-ten assent, where applicable...
- Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors [medulloblastomas, ATRT, EMTR, pineoblastoma], and ependymomas) diagnosis based on initial...
- Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecutive MRI or if they occur at least 12 weeks after completion of ra-diation therapy, or if there is clear...
- Male and female participants age ≥ 1 years and ≤ 25 years.
- A single measurable lesion longer than 10 mm in two perpendicular diameters, considered by the investigator to be accessible for safe stereotactic biopsy and virus injection.
- Lansky Performance Status (LPS) ≥ 60 for participants \< 16 years, or Karnofsky Performance Status (KPS) ≥ 60 for participants ≥ 16 years.
- No other chemotherapy or immunotherapy in the 4 weeks before inclusion.
- Steroids: free off or requiring decreasing or stable corticosteroid dose (≥ 0.05 mg/kg dexa-methasone daily, or equivalent for other steroids) in the 2 weeks before DNX-2401 admin-istration.
- Radiation: no craniospinal irradiation, total body irradiation nor focal irradiation in the 6 weeks before inclusion.
- Autologous Stem Cell Transplantation: patients must be ≥ 3 months post-transplant prior to entry of the study.
- Patients must be fully recovered from all acute treatment related toxicities of all prior therapies.
- Laboratory test: adequate hematological (platelets ≥ 100x10e9/L, neutrophils ≥ 1.0x10e9/L, hemoglobin ≥ 5,6 mmol/L), renal function (creatinine \<1.5 times ULN) and liver function (≤3 times ULN) values.
- Negative pregnancy test for female participants of child-bearing potential, where child-bearing potential is defined as a fertile female who is pubertal or post-pubertal and not permanently sterile (hysterectomy...
- Female participants of child-bearing potential, who are sexually active, agree to use ac-ceptable birth control starting at informed consent and continuing for at least 120 days af-ter DNX-2401 administration. Male...
- Any medical or psychological condition or disease that might interfere with the subject's ability to participate or give informed consent (if older than 16 years).
- Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system.
- Any treatment outside the allowable guidelines outlined in the inclusion criteria.
- Severe acute infection or intercurrent medical condition including, but not limited to se-vere renal, hepatic, heart or bone marrow failure that based on investigator discretion do not permit inclusion in the study.
- people with immunodeficiency or autoimmune conditions, active hepatitis or known HIV. No testing for Hepatitis B, Hepatitis C and HIV is required unless mandated by local health authority.
- people with another primary malignancy.
- Prior history of encephalitis, multiple sclerosis or other CNS infections or primary CNS dis-ease that would interfere with evaluation.
- Li Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its relat-ed pathways.
- Concurrent therapy with any antiviral drug or any immunosuppressive drug (except ster-oids).
- Life or life-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted.
- Prior participant in experimental viral therapy.
- Inability to undergo MRI scans for any reason.
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Netherlands
- Pamplona, Navarre, Spain
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 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, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Netherlands; Pamplona, Navarre, Spain. 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.