Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Diagnostic, Supportive care, Treatment	Active	2 to 21	Other	CCLG-CNS-2007-04 CNS 2007 04, EU-20746, EUDRACT-2007-001768-60, NCT00514397

Objectives

Primary

1. 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.
2. To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.

Secondary

1. 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.
2. 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.
3. To document radiological response to the above treatment with MR imaging and, where available, functional imaging.

Entry Criteria

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

Prior/Concurrent Therapy:

Exclusion criteria:

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

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

Expected Enrollment

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

Children's Cancer and Leukaemia Group

Simon Bailey, MD, Principal investigator		Ph: 44-191-282-5395

Ireland
	Dublin
	Our Lady's Hospital for Sick Children Crumlin
		Contact Person	Ph:  44-353-1-409-6659
United Kingdom
England
	Birmingham
	Birmingham Children's Hospital
		Martin English, MD	Ph:  44-121-333-8412
			Email: martin.english@bch.nhs.uk
	Bristol
	Bristol Royal Hospital for Children
		Contact Person	Ph:  44-117-342-0205
	Cambridge
	Addenbrooke's Hospital
		Amos Burke, MD	Ph:  44-1223-348-151
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Adam Glaser, MD	Ph:  44-113-206-4984
			Email: adam.glaser@leedsth.nhs.uk
	Leicester
	Leicester Royal Infirmary
		Johann Visser, MD	Ph:  44-116-258-5309
			Email: johannes.visser@uhl-tr.nhs.uk
	Liverpool
	Royal Liverpool Children's Hospital, Alder Hey
		Contact Person	Ph:  44-151-252-5294
	London
	Great Ormond Street Hospital for Children
		Contact Person	Ph:  44-20-7829-7924
	University College Hospital
		Contact Person	Ph:  44-20-7380-9950
	Manchester
	Royal Manchester Children's Hospital
		Bernadette Brennan, MD	Ph:  44-161-922-2227
			Email: bernadette.brennan@cmmc.nhs.uk
	Newcastle-Upon-Tyne
	Sir James Spence Institute of Child Health at Royal Victoria Infirmary
		Contact Person	Ph:  44-113-206-4985
	Nottingham
	Queen's Medical Centre
		Contact Person	Ph:  44-115-823-0620
	Oxford
	Oxford Radcliffe Hospital
		Contact Person	Ph:  44-1865-234-205
	Sheffield
	Children's Hospital - Sheffield
		Contact Person	Ph:  44-114-271-7366
	Southampton
	Southampton General Hospital
		Contact Person	Ph:  44-2380-794-101
	Sutton
	Royal Marsden - Surrey
		Contact Person	Ph:  44-20-8661-3455
Northern Ireland
	Belfast
	Royal Belfast Hospital for Sick Children
		Anthony McCarthy, MD	Ph:  44-289-063-3631
			Email: anthonymcarthy@royalhospital.n.i.nhs.uk
Scotland
	Aberdeen
	Royal Aberdeen Children's Hospital
		Veronica Neefjes	Ph:  44-1224-550-217
	Edinburgh
	Royal Hospital for Sick Children
		W. Hamish Wallace, MD	Ph:  44-131-536-0426
	Glasgow
	Royal Hospital for Sick Children
		Milind Ronghe, MD	Ph:  44-141-201-9309
Wales
	Cardiff
	Childrens Hospital for Wales
		Heidi Traunecker, MD, PhD	Ph:  44-29-2074-2285
			Email: heidi.traunecker@cardiffandvale.wales.nhs.uk

Registry Information
Official Title		A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide with Radiotherapy in Diffuse Pontine Gliomas
Trial Start Date		2008-01-07
Registered in ClinicalTrials.gov		NCT00514397
Date Submitted to PDQ		2007-07-16
Information Last Verified		2009-06-14

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