Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00514397
First received: August 8, 2007
Last updated: December 6, 2011
Last verified: June 2009

August 8, 2007
December 6, 2011
January 2008
Not Provided
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods [ Designated as safety issue: No ]
  • Overall survival
  • Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
Complete list of historical versions of study NCT00514397 on ClinicalTrials.gov Archive Site
  • Toxicity, steroid usage, and radiological response [ Designated as safety issue: Yes ]
  • Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria [ Designated as safety issue: Yes ]
  • Toxicity, steroid usage, and radiological response
  • Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Not Provided
Not Provided
 
Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: motexafin gadolinium
  • Drug: temozolomide
  • Procedure: adjuvant therapy
  • Procedure: quality-of-life assessment
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
43
Not Provided
Not Provided

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
Both
2 Years to 21 Years
No
Not Provided
Ireland,   United Kingdom
 
NCT00514397
CDR0000560114, CCLG-CNS-2007-04, EU-20746, EUDRACT-2007-001768-60
Not Provided
Not Provided
Children's Cancer and Leukaemia Group
Not Provided
Principal Investigator: Simon Bailey, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP