- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02481960
Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma (IDEB-glioma)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
CM-BC2, irinotecan hydrochloride drug-eluting bead, is an investigational product being developed for direct injection in the tumor resection margin, in patients with recurrent high grade glioma (HGG), in order to prevent or delay tumor progression or recurrence.
Patients will be enrolled and receive CM-BC2 following surgical resection of the recurrent high grade glioma and will attend specified study visits until 6 months post surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Male or female; no racial exclusions; at least 18 years of age
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
Intraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety measured by incidence of adverse events as assessed by CTCAE v4
Time Frame: 6 months
|
safety as measured by adverse events including changes in physical exams, neurological function
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Progression-free survival at 6 months
|
progression as assessed by MRI and date of death
|
Progression-free survival at 6 months
|
Serum levels of irinotecan
Time Frame: 6 months
|
serum levels of drug (irinotecan)
|
6 months
|
Serum levels of SN-38, irinotecan metabolite
Time Frame: 6 months
|
serum levels of drug metabolite (SN-38)
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- CA1018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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