GliomaPhase 1NCT02433392
Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.
A Phase 1 study testing CM-BC2 in people with Glioma, run by Boston Scientific Corporation at 1 site in United Kingdom.
Trial 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… 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Jul 2015
- Phase
- Phase 1
- 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 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
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- 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
- 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
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 GBM, or other neurosurgery within 30 days prior to study entry
- Multiple GBM lesions
- Irinotecan chemotherapy within 30 days prior to study treatment
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
About this study
Official title: A Phase 1 Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as an Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable Glioblastoma Multiforme.
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.
Read the detailed description
A challenge in the treatment of glioma is the delivery of treatment to the brain after systemic administration due to the blood brain barrier. To improve drug delivery to the brain to achieve very high local concentrations of the anti-neoplastic agent with low system toxicity, a local regional approach is proposed. CM-BC2, an irinotecan hydrochloride drug-eluting bead, is an investigational medicinal product intended for direction injection into the tumor resection margin. The objective of this trial is demonstration of safety and feasibility of this intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent Glioblastoma multiforme.
- Conditions
- Glioma
- Being tested
- CM-BC2
- Keywords
- drug-eluting beads, irinotecan hydrochloride
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-BC2Procedure or surgery
CM-BC2 is a drug-eluting bead, a drug-device combination
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: CM-BC2 |
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 v4.0
safety of intraparenchymal injection of CM-BC2
Measured: 6 months
Secondary outcomes (3)
Progression-free survival
Progression-free Survival (PFS) at 6 months
Measured: 6 months
Systemic serum levels of irinotecan
Serum levels of drug (irinotecan)
Measured: 6 months
Systemic 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 posted5 May 2015 (estimated)
- Study startDec 2011
- Primary completionJul 2015
- Study completionJul 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Garth Cruickshank, M.D., Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433392
- Sponsor's protocol ID
- CA1021
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 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 1 Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as an Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT02433392
- Acronym / sponsor ID
- CA1021
- Conditions
- Glioma
- Keywords
- drug-eluting beads, irinotecan hydrochloride
- Phase
- Phase 1
- 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
- 9 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Birmingham
- Study start
- Dec 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 May 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.
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.
Detailed description
A challenge in the treatment of glioma is the delivery of treatment to the brain after systemic administration due to the blood brain barrier. To improve drug delivery to the brain to achieve very high local concentrations of the anti-neoplastic agent with low system toxicity, a local regional approach is proposed. CM-BC2, an irinotecan hydrochloride drug-eluting bead, is an investigational medicinal product intended for direction injection into the tumor resection margin. The objective of this trial is demonstration of safety and feasibility of this intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent Glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM-BC2 | Experimental | Procedure: CM-BC2Patients diagnosed with recurrent, surgically resectable glioblastoma multiforme will receive up to 75 mg irinotecan delivered by drug-eluting beads (CM-BC2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- patient will have received conventional treatment at the time of initial diagnosis, including surgery (biopsy or de-bulking), and/or radiotherapy, and/or chemotherapy
Key exclusion criteria (15 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 GBM, or other neurosurgery within 30 days prior to study entry
- Multiple GBM lesions
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-BC2CM-BC2 is a drug-eluting bead, a drug-device combination | Procedure or surgery | CM-BC2 |
Primary outcome
Safety measured by incidence of adverse events as assessed by CTCAE v4.0
Time frame: 6 months
safety of intraparenchymal injection of CM-BC2
3 secondary outcomes
Progression-free survival
Time frame: 6 months
Systemic serum levels of irinotecan
Time frame: 6 months
Systemic 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.
Garth Cruickshank, M.D. principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM-BC2 in people with Glioma, run by Boston Scientific Corporation at 1 site in United Kingdom.
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 12 inclusion and 15 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 1 site in United Kingdom. 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 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.
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 v4.0 (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.