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INTRATUMORAL DNX-2401 ADMINISTRATION FOR RECURRENT AND REFRACTORY HIGH GRADE BRAIN TUMORS IN PEDIATRIC AND YOUNG ADULT PATIENTS
EU CTIS ID: 2024-515009-24-00
What this study is testing
To determine if single intratumoral administration of DNX-2401 in recommended phase II dose of 5x10¹⁰ viral particles elicits tumor response in children with recurrent/refractory high grade brain tumors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 the pediatric participant provides written assent, where applicable, based on age and country requirements.
- 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 ≥ 100x10⁹/L, neutrophils ≥ 1.0x10⁹/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, bilateral salpingectomy, bilateral oophorectomy).
- Female participants of child-bearing potential, who are sexually active, agree to use acceptable birth control starting at informed consent and continuing for at least 120 days after DNX-2401 administration. Male participants agree to use acceptable birth control starting at informed consent and continuing for at least 90 days after DNX-2401 administration.
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 than 16 years).
- 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.
- Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system.
See the full eligibility criteria
Who can join
- The participant or participant’s parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides written assent, where applicable, based on age and country requirements.
- 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 ≥ 100x10⁹/L, neutrophils ≥ 1.0x10⁹/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, bilateral salpingectomy, bilateral oophorectomy).
- Female participants of child-bearing potential, who are sexually active, agree to use acceptable birth control starting at informed consent and continuing for at least 120 days after DNX-2401 administration. Male participants agree to use acceptable birth control starting at informed consent and continuing for at least 90 days after DNX-2401 administration.
- 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 histopathological diagnosis and further clinical and radiological follow-up, in whom gross total resection is not feasible, and with a life expectancy of at least 16 weeks at the time of consent.
- 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 radiation therapy, or if there is clear histopathological confirmation of tumor recurrence.
- 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 dexamethasone daily, or equivalent for other steroids) in the 2 weeks before DNX-2401 administration.
- Radiation: no craniospinal irradiation, total body irradiation nor focal irradiation in the 6 weeks before inclusion.
What rules you out
- 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).
- 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.
- 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 severe renal, hepatic, heart or bone marrow failure that based on investigator discretion do not permit inclusion in the study.
- Subjects 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.
- Subjects with another primary malignancy.
- Prior history of encephalitis, multiple sclerosis or other CNS infections or primary CNS disease that would interfere with evaluation.
- Li-Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its related pathways.
- Concurrent therapy with any antiviral drug or any immunosuppressive drug (except steroids).
The study team makes the final eligibility decision.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.