ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors

Brainstem Glioma Clinical Trial

Official title:

ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756989
• Other study ID #: Angiocomb
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2011
• Last updated: May 7, 2014
• Start date: January 2005
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

-pediatric diffuse brainstem tumor

Exclusion Criteria:

• wish of the family

• need for strong painrelievers

• decreased level of consciousness

• inability to swallow.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brainstem Glioma

Intervention

Drug:
• Thalidomide, etoposide, 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.

Locations

Country	Name	City	State
Finland	Div of Hem/Onc and SCT, Children's Hospital, HUCH	Helsinki

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Primary outcome measure is survival in months.	up to five years	No