Brainstem GliomaPhase 2NCT01756989
ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
A Phase 2 study testing Thalidomide, etoposide, celecoxib in people with Brainstem Glioma, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Brainstem Glioma
- What is being tested?
- Thalidomide, etoposide, celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2005to Dec 2013
- Phase
- Phase 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -pediatric diffuse brainstem tumor
Who cannot join
- wish of the family
- need for strong painrelievers
- decreased level of consciousness
- inability to swallow.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Div of Hem/Onc and SCT, Children's Hospital, HUCH
Helsinki, 00029
About this study
The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.
Read the detailed description
All pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in Denmark, Finland, Iceland, Norway and Sweden will be eligible. A possible tumor biopsy with histologic findings is not taken into account. The diagnosis is based on MRI. The patients are given a conventional local radiotherapy of 54 Gy, during which the patient also receives topotecan as radiosensitizer. Within four weeks after completed radiotherapy, the investigational drugs are started. If the family for some reason refuses radiotherapy, the investigational therapy may still be considered. The guardians and age-appropriate patients are asked for written informed consent. If the family is not willing to participate in the trial, the patient is treated according to the currently best available therapy (meaning RT without topotecan as palliative therapy). The family has the right to withdraw from the study, whenever they so wish.
Brain MRI at initial diagnosis, before the start of triple medication, and q 3 mo after initiation of triple medication, if not otherwise clinically indicated. In case it is decided to continue medication with progression in MRI, repeat MRIs are recommended every month. MRI should also be registered, if feasible, at the discontinuation of the medication.
The clinical follow-up, as well as MRI follow-up, on clinical indications will continue also after discontinuation of therapy.
PET-CT and/or MRI spectroscopy should be considered at diagnosis and at 3 mo after the start of triple medication.
- Conditions
- Brainstem Glioma
- Being tested
- Thalidomide, etoposide, celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide, etoposide, celecoxibDrug
Also called vepesid (etoposide), celebra (celecoxib)
Thalidomide p.o. 1 mg/kg/day/1; the dose is gradually escalated, the maximum dose being 6 mg/kg/day. (The individual dose is set based on adverse effects.) Celecoxib p.o. 230 mg/m2/day/1-2, or in small children at 7 mg/kg/day in 1-2 doses.
Etoposide p.o. the initial dosage 20 mg/m2/day; the dose is gradually escalated, the maxi 70 mg/m2/day.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide, etoposide, celecoxib | Experimental | Single arm study,phase II Receives: Drug: Thalidomide, etoposide, celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Primary outcome measure is survival in months.
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2005
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brainstem GliomaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital
- Responsible party
- Principal investigator, Sanna-Maria Kivivuori, Helsinki University Central Hospital
- Investigators
- Sanna-Maria Kivivuori, md, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756989
- Sponsor's protocol ID
- Angiocomb
- Status last verified
- May 2014
- First submitted
- 18 May 2011
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
- ClinicalTrials.gov ID
- NCT01756989
- Acronym / sponsor ID
- Angiocomb
- Conditions
- Brainstem Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital
- Study start
- Jan 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Dec 2012 (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 study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.
Detailed description
All pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in Denmark, Finland, Iceland, Norway and Sweden will be eligible. A possible tumor biopsy with histologic findings is not taken into account. The diagnosis is based on MRI. The patients are given a conventional local radiotherapy of 54 Gy, during which the patient also receives topotecan as radiosensitizer. Within four weeks after completed radiotherapy, the investigational drugs are started. If the family for some reason refuses radiotherapy, the investigational therapy may still be considered. The guardians and age-appropriate patients are asked for written informed consent. If the family is not willing to participate in the trial, the patient is treated according to the currently best available therapy (meaning RT without topotecan as palliative therapy). The family has the right to withdraw from the study, whenever they so wish.
Brain MRI at initial diagnosis, before the start of triple medication, and q 3 mo after initiation of triple medication, if not otherwise clinically indicated. In case it is decided to continue medication with progression in MRI, repeat MRIs are recommended every month. MRI should also be registered, if feasible, at the discontinuation of the medication.
The clinical follow-up, as well as MRI follow-up, on clinical indications will continue also after discontinuation of therapy.
PET-CT and/or MRI spectroscopy should be considered at diagnosis and at 3 mo after the start of triple medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide, etoposide, celecoxib | Experimental | Drug: Thalidomide, etoposide, celecoxibSingle arm study,phase II |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -pediatric diffuse brainstem tumor
Key exclusion criteria (4 listed)
- wish of the family
- need for strong painrelievers
- decreased level of consciousness
- inability to swallow.
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 |
|---|---|---|
| Thalidomide, etoposide, celecoxibAlso: vepesid (etoposide), celebra (celecoxib)Thalidomide p.o. 1 mg/kg/day/1; the dose is gradually escalated, the maximum dose being 6 mg/kg/day. (The individual dose is set based on adverse effects.) Celecoxib p.o. 230 mg/m2/day/1-2, or in small children at 7 mg/kg/day in 1-2 doses. Etoposide p.o. the initial dosage 20 mg/m2/day; the dose is gradually escalated, the maxi 70 mg/m2/day. | Drug | Thalidomide, etoposide, celecoxib |
Primary outcome
Survival
Time frame: up to five years
Primary outcome measure is survival in months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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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.
Sanna-Maria Kivivuori, md study chair
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide, etoposide, celecoxib in people with Brainstem Glioma, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2014. 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 Finland. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival (time frame: up to five years). 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 8 May 2014.