Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma

• Register: ClinicalTrials.gov
• Last refreshed on: 3 May 2021
• Main ID: NCT02481960
• Date of registration: 23/06/2015
• Prospective Registration: No
• Primary sponsor: Boston Scientific Corporation
• Public title: Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma IDEB-glioma
• Scientific title: A Phase I/II Multi Centre Single Arm, Open Label Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as a Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable High Grade Glioma
• Date of first enrolment: February 21, 2012
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02481960
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of Glioblastoma Multiforme (GBM) (World Health
Organization grade III or IV)

2. Patient will be considered a good candidate for resection and will have estimated life
expectancy of at least 12 weeks as estimated by the Principal Investigator or
designee. The decision to opt for resection of the recurrence must be independent of
study selection.

3. Tumour characteristics:

- Single unilateral and supratentorial lesion

- On clinician's assessment, must be operable under normal considerations of risk
vs. benefit for condition and prognosis

4. Patient will have received conventional treatment at the time of initial diagnosis,
including surgery (biopsy or de-bulking), and/or radiotherapy, and/or chemotherapy

5. Male or female; no racial exclusions; at least 18 years of age

6. Pregnancy must be excluded in female patients by beta- HCG (Human Chorionic
Gonadotropin); all patients agree to use adequate contraception for study duration,
not become pregnant or father children during the study

7. Karnofsky Performance Status of at least 50

8. Patients must be able to understand consent and study instructions as well as follow
prescribed instructions

9. Patient must have signed written informed consent prior to study participation

Exclusion Criteria:

1. Patient must not be enrolled in any other clinical trial for 30 days before or after
participation in this trial

2. History of allergic reactions attributed to compounds of similar chemical make-up or
composition to CM-BC2, alginate or irinotecan; or has any other contraindications to
irinotecan therapy

3. Open communication between the ventricle CSF (cerebrospinal fluid) and tumour
resection cavity/site must be avoided. In the case of opening ventricles during
surgery, the surgeon must decide whether effective closure is possible by obstructing
the gap with Gelfoam/other appropriate materials

4. Tumor surgery, other than stereotactic biopsy of the high grade glioma, or other
neurosurgery within 30 days prior to study entry

5. Irinotecan chemotherapy within 30 days prior to study treatment

6. Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study
entry

7. Loco-regional (intra-cranial) therapy for the treatment of high grade glioma,
including administration of biodegradable polymer wafers containing Carmustine and/or
brachytherapy, in the 6 months prior to study entry

8. Significant liver function impairment: aminotransferase (AST) or alanine transaminase
(ALT) greater than 2.5 x the upper limit of normal (ULN), or total bilirubin greater
than 2 x ULN

9. Significant renal impairment: creatinine greater than 2.0 mg/dL

10. Coagulopathy Prothrombin time (PT) or partial thromboplastin time (APTT) of less than
1.5 x control, and/or platelet count of less than 100 x 10?/L

11. Hb less than 8 g/dL and/or neutrophil count (ANC - Absolute Neutrophil Count) of less
than 1 x 10?/L

12. Any condition that, in the investigator's opinion, makes it in the patient's best
interest not to participate in the study

13. Pre-existing cerebral oedema that, in the surgeon's opinion, poses unacceptable risk
of post-operative oedema. This decision may be at time of surgery.

14. Presence of concurrent malignancy, except for adequately controlled limited basal cell
carcinoma of the skin or carcinoma in situ of the cervix



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glioma

Intervention(s)

Procedure: CM-BC2 Irinotecan drug-eluting bead

Primary Outcome(s)

Safety measured by incidence of adverse events as assessed by CTCAE v4 [Time Frame: 6 months]

Secondary Outcome(s)

Serum levels of SN-38, irinotecan metabolite [Time Frame: 6 months]

Serum levels of irinotecan [Time Frame: 6 months]

Progression-free survival [Time Frame: Progression-free survival at 6 months]

Secondary ID(s)

CA1018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors