Clinical trial NCT01756989: ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
Official title: ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brainstem Glioma
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Turku University Hospital
First posted: 2012-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-pediatric diffuse brainstem tumor

Exclusion Criteria:

* wish of the family
* need for strong painrelievers
* decreased level of consciousness
* inability to swallow.

Primary outcomes:
measure: Survival
timeFrame: up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Div of Hem/Onc and SCT, Children's Hospital, HUCH
Study officials:
affiliation: Helsinki University Central Hospital
name: Sanna-Maria Kivivuori, md
role: STUDY_CHAIR
References: