Irinotecan-ChemoSeed in Resectable Glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, non-randomised trial with two parts. Part 1 enrolls 12 patients with recurrent GBM to test safety, determine the maximum tolerated dose and recommended phase 2 dose of irinotecan-ChemoSeed when given with standard care. Part 2 plans to enroll 135 patients with newly diagnosed GBM to evaluate efficacy after maximal safe resection. The irinotecan-chemo seed is implanted into the resection cavity at the surgeon’s discretion within the dose limits. Participants must be adults with adequate organ function and a good performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 time period. 8. Male participants of reproductive potential, who intend to be sexually active with a female partner of childbearing potential, must commit to use barrier contraception (e.g., condom) 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. Male participants must not donate or bank sperm during the same time period.

      Exclusion Criteria:
* 1\. Multicentric disease defined by tumours which have multiple discrete areas of contrast enhancing or non-enhancing tumour without connecting T2/ fluid-attenuated inversion recovery (FLAIR) signal abnormality. 2. Diffuse leptomeningeal disease. 3. Not eligible for surgical resection. 4. Known hypersensitivity to IRN or PLGA. 5. Prior IRN treatment (for Part 2 participants) less than 12 months from trial enrolment 6. Pregnant or lactating women or participants who intend to get pregnant during the trial.

  7\. Prior active malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to surgical resection and trial drug administration. 8. Part 1 participants with relapsed GBM: treatment with another investigational drug or other intervention within 4 weeks prior to the surgical resection or 5 times the half-life (whichever is longer) before trial drug administration. 9. Part 2 participants with newly diagnosed GBM: prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.

Where it's running

• University Hospitals Birmingham NHS Foundation Trust
  Birmingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Chris McConville, Pr
• Email: chrismcconville@extrudedpharmaceuticals.com
• Phone: +44 (0) 78342 67819

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.