ClinicaliQ Trial Snapshot
- Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma — Recruiting • Phase II • Oncology • NCT07356973.
- What is being tested: Irinotecan-ChemoSeed, a locally-delivered chemotherapy implant, is being evaluated for safety, tolerability, and maximum tolerated dose (MTD) in patients undergoing surgical resection for recurrent glioblastoma multiforme (GBM).
- Patient eligibility overview: Part 1 enrolls 12 participants with recurrent GBM who are candidates for maximal safe surgical resection, representing a carefully selected population with performance status suitable for this invasive intervention.
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What This Trial Is Studying
Part 1 (dose escalation, safety, and preliminary efficacy) Part 1 is a non-randomised, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection. Part 1 will evaluate safety, determine the MTD of irinotecan-ChemoSeed and the RP2D (corresponding to coverage of as much of the resection cavity as possible, up to the MTD) and evaluate efficacy. All Part 1 participants will be administered irinotecan- ChemoSeed concurrent to Standard of Care (SoC) treatment. Part 1 dose- escalation will start at 72 mg of IRN Part 2, in 135…
Eligibility Snapshot
- : * 1. Radiologically relapsed, neuropathologically verified GBM (by the WHO 2021 criteria) (Part 1) or newly diagnosed, radiologically suspected GBM (Part 2) amenable to surgical resection. 2. Male or female aged 18 years or older. 3. Ability to understand and the willingness to sign a written informed consent form (ICF). 4. KPS ≥ 70. 5. Life expectancy ≥ 6 months. 6. Adequate organ and marrow function as follows (all required): 1. Absolute neutrophil count ≥ 1.5 k/µL 2. Platelets ≥ 100 k/µL 3. Haemoglobin ≥ 9 g/dL 4. Serum creatinine ≤ 1.8 mg/dL or creatinine clearance > 50 mL/min 5. Bilirubin ≤ 1.5 mg/dL 6. Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN) 7. Aspartate aminotransferase (AST) ≤ 3.0 × ULN 8. Prothrombin time ≤ 1.5 × ULN 9. International normalised ratio (INR) ≤ 1.5 × ULN 10. Partial thromboplastin time ≤ 1.5 × ULN 7. Women of childbearing potential must agree to use a highly effective method of contraception for the duration of the trial or for 5X the systemic half-life (i.e., 6 weeks) plus 6 months following irinotecan-ChemoSeed administration, whichever is the longest.. Female participants must refrain from egg donation during the same…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.