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

This study has been completed.
Sponsor:
Collaborators:
Kuopio University Hospital
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Information provided by (Responsible Party):
Sanna-Maria Kivivuori, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01756989
First received: May 18, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Brainstem Glioma
Drug: Thalidomide, etoposide, celecoxib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: up to five years ] [ Designated as safety issue: No ]
    Primary outcome measure is survival in months.


Estimated Enrollment: 50
Study Start Date: January 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-pediatric diffuse brainstem tumor

Exclusion Criteria:

  • wish of the family
  • need for strong painrelievers
  • decreased level of consciousness
  • inability to swallow.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756989

Locations
Finland
Div of Hem/Onc and SCT, Children's Hospital, HUCH
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Kuopio University Hospital
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Investigators
Study Chair: Sanna-Maria Kivivuori, md Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Sanna-Maria Kivivuori, Sanna-Maria Kivivuori/Consultant in Pediatric Hematology and Oncology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01756989     History of Changes
Other Study ID Numbers: Angiocomb
Study First Received: May 18, 2011
Last Updated: May 7, 2014
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Celecoxib
Etoposide
Etoposide phosphate
Thalidomide
Analgesics
Analgesics, Non-Narcotic
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014