CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours

ConditionLocally Resectable Paediatric Tumours

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeUp to 18

SponsorCEBIOTEX

About this trial

The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the abdominal cancer tumor, CEB-01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of abdominal tumors after surgery, while keeping a tolerable toxicity profile.

The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in pediatric patients with locally resectable abdominal tumors including Soft Tissue Sarcoma (STS), high-risk Neuroblastoma (NB), Wilms tumour (WT), germ cell tumors (GCT), extracranial malignant rhabdoid tumour (eMRT), synovial sarcoma (SS), desmoplastic small round cell tumour (DSRCT) and fibrolamellar hepatocellular carcinoma (FL-HCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≤ 18 years.

De novo or recurrent abdominal soft-tissue sarcoma.

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.

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.

Disqualifiers

Metastatic lesions.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Standard surgery
Procedure/Surgery
The location and size of the tumor determine the type of surgery.
CEB-01
Drug
It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Standard surgery and CEB-01 implant after surgeryExperimental treatment 2 interventions

Group B: Active Comparator: Arm 2 standard surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

Frequency of Adverse Events (AEs) (Safety)

Adverse Events (AE), serious and non-serious, with their frequency, severity, and relatedness to study drug and coded according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE).

Time frame