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

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.

Study Overview

• Status: Completed
• Conditions: Brainstem Glioma
• Intervention / Treatment: Drug: Thalidomide, etoposide, celecoxib

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Div of Hem/Onc and SCT, Children's Hospital, HUCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-pediatric diffuse brainstem tumor

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Thalidomide, etoposide, celecoxib; Single arm study,phase II

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.; Other Names: vepesid (etoposide); celebra (celecoxib)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Primary outcome measure is survival in months.	up to five years

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University Hospital
• Investigators: Study Chair: Sanna-Maria Kivivuori, md, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (ESTIMATE): December 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cyclooxygenase 2 Inhibitors; Etoposide; Etoposide phosphate; Thalidomide; Celecoxib
• Other Study ID Numbers: Angiocomb