GliomaPhase 1/2IDEB-gliomaNCT02481960
Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma
A Phase 1/2 study testing CM-BC2 Irinotecan drug-eluting bead in people with Glioma, run by Boston Scientific Corporation at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- CM-BC2 Irinotecan drug-eluting bead
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2012to 18 Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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).
Read the 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.
- Conditions
- Glioma
- Being tested
- CM-BC2 Irinotecan drug-eluting bead
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-BC2 Irinotecan drug-eluting beadProcedure or surgery
Also called IDEB
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Intraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma. Receives: Procedure: CM-BC2 Irinotecan drug-eluting bead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Progression-free survival
progression as assessed by MRI and date of death
Measured: Progression-free survival at 6 months
Serum levels of irinotecan
serum levels of drug (irinotecan)
Measured: 6 months
Serum levels of SN-38, irinotecan metabolite
serum levels of drug metabolite (SN-38)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start21 Feb 2012
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Why it stopped: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481960
- Sponsor's protocol ID
- CA1018
- Acronym
- IDEB-glioma
- Status last verified
- Apr 2021
- First submitted
- 23 Jun 2015
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02481960
- Acronym / sponsor ID
- IDEB-glioma / CA1018
- Conditions
- Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies\]
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2012 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Procedure: CM-BC2 Irinotecan drug-eluting beadIntraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-BC2 Irinotecan drug-eluting beadAlso: IDEB | Procedure or surgery | Treatment arm |
Primary outcome
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
3 secondary outcomes
Progression-free survival
Time frame: Progression-free survival at 6 months
Serum levels of irinotecan
Time frame: 6 months
Serum levels of SN-38, irinotecan metabolite
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM-BC2 Irinotecan drug-eluting bead in people with Glioma, run by Boston Scientific Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies\]). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by incidence of adverse events as assessed by CTCAE v4 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.