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CEB-01 in paediatrics with locally resectable abdominal tumours.
EU CTIS ID: 2024-520054-38-00
What this study is testing
To assess the safety and tolerability of CEB-01.
- 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
- Age ≤18 years.
- Female and male participants of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
- Life expectancy greater than 6 months.
- The participant’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.
- Participants must have a diagnosis of: a.De novo or recurrent abdominal soft-tissue sarcoma. b.De novo or recurrent high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification, regardless of response to frontline therapy, diagnosed either by a former histologic verification of neuroblastoma and/or former demonstration of tumour cells in the bone marrow with increased urinary catecholamines at the time of study enrolment. Participants who were initially considered low or intermediate risk but were then reclassified as high risk are also eligible. c.Other tumours: recurrent Wilms tumour, de novo or recurrent Germ cell tumour, de novo or recurrent extracranial malignant rhabdoid tumour, de novo or recurrent synovial sarcoma, de novo or recurrent fibrolamellar hepatocellular carcinoma, and de novo or recurrent desmoplastic small round cell tumour.
- A histology assessment is required for enrolment of de novo cases cases, except for patients with high-risk neuroblastoma for which a radioiodine-labelled meta-iodo-benzyl-guanidine (MIBG) test is positive and excess of production od catecholamines is confirmed. A new histology assessment is not required for enrolment of the recurrent cases, but it will be obtained from the resected tumour to assess whether the histology is identical to the original tumour.
You likely can't join if
- Metastatic lesions that in the investigator’s opinion will not jeopardize the assessment of efficacy and safety.
- Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Contraindication to computed tomography (CT) scan.
- Major surgery within 14 days prior to the implant of study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.
- Other relevant concomitant illnesses.
- Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.
See the full eligibility criteria
Who can join
- Age ≤18 years.
- Female and male participants of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
- Life expectancy greater than 6 months.
- The participant’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.
- Participants must have a diagnosis of: a.De novo or recurrent abdominal soft-tissue sarcoma. b.De novo or recurrent high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification, regardless of response to frontline therapy, diagnosed either by a former histologic verification of neuroblastoma and/or former demonstration of tumour cells in the bone marrow with increased urinary catecholamines at the time of study enrolment. Participants who were initially considered low or intermediate risk but were then reclassified as high risk are also eligible. c.Other tumours: recurrent Wilms tumour, de novo or recurrent Germ cell tumour, de novo or recurrent extracranial malignant rhabdoid tumour, de novo or recurrent synovial sarcoma, de novo or recurrent fibrolamellar hepatocellular carcinoma, and de novo or recurrent desmoplastic small round cell tumour.
- A histology assessment is required for enrolment of de novo cases cases, except for patients with high-risk neuroblastoma for which a radioiodine-labelled meta-iodo-benzyl-guanidine (MIBG) test is positive and excess of production od catecholamines is confirmed. A new histology assessment is not required for enrolment of the recurrent cases, but it will be obtained from the resected tumour to assess whether the histology is identical to the original tumour.
- Participants previously treated with irinotecan will be eligible if they have not had documented progressive disease during treatment.
- Participants might have more than one surgically removable lesion.
- Adequate liver, renal, haematological, and cardiac function as defined by biochemical and haematological parameters as follows: haemoglobin (Hb) >9 g/dL (with preoperative transfusion), platelets >80.000/mm3 with intraoperative transfusion, absolute neutrophil count ≥ 1.500/mm3 or below this threshold if there is clinical indication that the patient is on hematological recovery, albumin >3.0 g/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2,5 times the upper limit of normality [ULN], bilirubin <2 times the ULN, creatinine <1,0 mg/dl or creatinine clearance > 60 ml/min.
- Participants must have fully recovered from the acute toxic clinically relevant effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.
- Lansky or Karnofsky functional performance status score ≥ 50 at screening.
- Female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
What rules you out
- Metastatic lesions that in the investigator’s opinion will not jeopardize the assessment of efficacy and safety.
- Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Contraindication to computed tomography (CT) scan.
- Major surgery within 14 days prior to the implant of study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.
- Other relevant concomitant illnesses.
- Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.
- Participants’ status post-allogeneic stem cell transplant are not eligible.
- Participants with disease of any major organ system that would compromise their ability to withstand therapy.
- Patients with tumour size requiring CEB-01 implant that exceeds the maximum implantable surface area based on Body Surface Area (BSA) correction.
- Patients with known hypersensitivity to SN-38 or any of the CEB-01 excipients.
- Other malignancies within past 2 years, except for in-situ cancers or basal/squamous cell skin cancer. Subjects with other malignancies are eligible if they are disease-free for at least 24 months or have a clinically stable concurrent malignancy not requiring tumour-directed treatment.
- Active bacterial, viral or fungal infection.
- Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.
- Impossibility of ensuring adequate follow-up.
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, 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.