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

NCT02481960 | Terminated Phase 1 DMC

• 1 other identifier: CA1018
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Safety measured by incidence of adverse events as assessed by CTCAE v4

  safety as measured by adverse events including changes in physical exams, neurological function

  6 months

Secondary Outcomes (3)

• Progression-free survival

  Progression-free survival at 6 months

• Serum levels of irinotecan

  6 months

• Serum levels of SN-38, irinotecan metabolite

  6 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Intraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma.

Procedure: CM-BC2 Irinotecan drug-eluting bead

Interventions

CM-BC2 Irinotecan drug-eluting bead PROCEDURE

Also known as: IDEB

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of Glioblastoma Multiforme (GBM) (World Health Organization grade III or IV)
• 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.
• 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
• Patient will have received conventional treatment at the time of initial diagnosis, including surgery (biopsy or de-bulking), and/or radiotherapy, and/or chemotherapy
• 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
• Karnofsky Performance Status of at least 50
• Patients must be able to understand consent and study instructions as well as follow prescribed instructions
• Patient must have signed written informed consent prior to study participation

You may not qualify if:

• Patient must not be enrolled in any other clinical trial for 30 days before or after participation in this trial
• 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
• 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
• Tumor surgery, other than stereotactic biopsy of the high grade glioma, or other neurosurgery within 30 days prior to study entry
• Irinotecan chemotherapy within 30 days prior to study treatment
• Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry
• 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
• 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
• Significant renal impairment: creatinine greater than 2.0 mg/dL
• 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 10⁹/L
• Hb less than 8 g/dL and/or neutrophil count (ANC - Absolute Neutrophil Count) of less than 1 x 10⁹/L
• Any condition that, in the investigator's opinion, makes it in the patient's best interest not to participate in the study
• 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.
• Presence of concurrent malignancy, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Centre Hopsitalier Universitaire d'Angers

Angers, 49933, France

Location

Prof. Erol Sandalcioglu

Hanover, 30167, Germany

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: February 21, 2012
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

FR (1); DE (1)