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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756989
First Posted: December 28, 2012
Last Update Posted: May 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: Intervention Model: Single Group Assignment
Masking: None (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 Sanna-Maria Kivivuori, Helsinki University Central Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: up to five years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 18, 2011
First Posted: December 28, 2012
Last Update Posted: May 8, 2014
Last Verified: May 2014

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