Clinical Trial: Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.

    Sponsor: Children's Cancer and Leukaemia Group

    Current Primary Outcome:

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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

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


    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: August 8, 2007
    Date Started: January 2008
    Date Completion:
    Last Updated: August 9, 2013
    Last Verified: June 2009