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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Cancer and Leukaemia Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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