Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

August 9, 2013 updated by: Children's Cancer and Leukaemia Group

A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
  • To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.

Secondary

  • To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
  • To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group.
  • To document radiological response to the above treatment with MR imaging and, where available, functional imaging.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy: Patients receive oral temozolomide once daily for 6 weeks (7 days per week) with concurrent radiotherapy (5 days per week).

Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy.

  • Maintenance therapy: Patients receive oral temozolomide daily on days 1-21. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to chemoradiotherapy and prior to course 1 of adjuvant temozolomide and prior to every 3 subsequent courses of adjuvant temozolomide.

After completion of study therapy, patients are followed every 8 weeks.

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 12
        • Recruiting
        • Our Lady's Hospital for Sick Children Crumlin
        • Contact:
          • Contact Person
          • Phone Number: 44-353-1-409-6659
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Children's Hospital
      • Bristol, England, United Kingdom, BS2 8AE
        • Recruiting
        • Bristol Royal Hospital for Children
        • Contact:
          • Contact Person
          • Phone Number: 44-117-342-0205
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
      • Liverpool, England, United Kingdom, L12 2AP
        • Recruiting
        • Royal Liverpool Children's Hospital, Alder Hey
        • Contact:
          • Contact Person
          • Phone Number: 44-151-252-5294
      • London, England, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7829-7924
      • London, England, United Kingdom, NW1 2BU
        • Recruiting
        • University College Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7380-9950
      • Manchester, England, United Kingdom, M27 4HA
        • Recruiting
        • Royal Manchester Children's Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
        • Recruiting
        • Sir James Spence Institute of Child Health at Royal Victoria Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-113-206-4985
      • Nottingham, England, United Kingdom, NG7 2UH
        • Recruiting
        • Queen's Medical Centre
        • Contact:
          • Contact Person
          • Phone Number: 44-115-823-0620
      • Oxford, England, United Kingdom, 0X3 9DU
        • Recruiting
        • Oxford Radcliffe Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1865-234-205
      • Sheffield, England, United Kingdom, S10 2TH
        • Recruiting
        • Children's Hospital - Sheffield
        • Contact:
          • Contact Person
          • Phone Number: 44-114-271-7366
      • Southampton, England, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-2380-794-101
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
        • Contact:
          • Contact Person
          • Phone Number: 44-20-8661-3455
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BE
        • Recruiting
        • Royal Belfast Hospital for Sick Children
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZG
        • Recruiting
        • Royal Aberdeen Children's Hospital
      • Edinburgh, Scotland, United Kingdom, EH9 1LF
        • Recruiting
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, United Kingdom, G3 8SJ
        • Recruiting
        • Royal Hospital for Sick Children
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Recruiting
        • Childrens Hospital for Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI

    • No requirement for histological diagnosis
    • Clinical history < 6 months

  • Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:

    • Cranial nerve deficit
    • Long tract signs
    • Ataxia

Exclusion criteria:

  • Focal lesions of brainstem
  • Predominantly exophytic tumors

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)
  • Life expectancy > 12 weeks
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Urea and serum creatinine < 1.5 times upper limit of normal (ULN)
  • Total and direct bilirubin < 1.5 times ULN
  • AST and ALT < 3 times ULN
  • Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential

Exclusion criteria:

  • Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)
  • Pregnant or breast-feeding women

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Prior chemotherapy or radiotherapy
  • Other concurrent investigational drugs
  • Other concurrent chemotherapy, immunotherapy, or biologic therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods

Secondary Outcome Measures

Outcome Measure
Toxicity, steroid usage, and radiological response
Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer and Leukaemia Group

Investigators

  • Principal Investigator: Simon Bailey, MD, Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCLG-CNS-2007-04
  • CDR0000560114 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20746
  • EUDRACT-2007-001768-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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