Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.

NCT02433392 | Terminated Phase 1 DMC

• 1 other identifier: CA1021
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine the safety and feasibility of injecting irinotecan hydrochloride drug-eluting beads directly into the cavity remaining after a tumor is surgically removed in patients with a type of brain tumor (glioblastoma multiforme - also known as glioma) that has returned after prior therapy.

Conditions

Glioma

Keywords

drug-eluting beads; irinotecan hydrochloride

Outcome Measures

Primary Outcomes (1)

• Safety measured by incidence of adverse events as assessed by CTCAE v4.0

  safety of intraparenchymal injection of CM-BC2

  6 months

Secondary Outcomes (3)

• Progression-free survival

  6 months

• Systemic serum levels of irinotecan

  6 months

• Systemic serum levels of SN-38, irinotecan metabolite

  6 months

Study Arms (1)

CM-BC2

EXPERIMENTAL

Patients diagnosed with recurrent, surgically resectable glioblastoma multiforme will receive up to 75 mg irinotecan delivered by drug-eluting beads (CM-BC2).

Procedure: CM-BC2

Interventions

CM-BC2 PROCEDURE

CM-BC2 is a drug-eluting bead, a drug-device combination

CM-BC2

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 IV)
• recurrent disease
• 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
• Karnofsky Performance Status of at least 60
• 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 GBM, or other neurosurgery within 30 days prior to study entry
• Multiple GBM lesions
• 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 GBM, 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
• University of Birmingham: collaborator

Study Sites (1)

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

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 Officials

• Garth Cruickshank, M.D.

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

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: April 24, 2015
• First Posted: May 5, 2015
• Study Start: December 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

GB (1)