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: August 9, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: motexafin gadolinium
Drug: temozolomide
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 43
Study Start Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514397

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Contact Person    44-353-1-409-6659      
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD    44-121-333-8412    martin.english@bch.nhs.uk   
Bristol Royal Hospital for Children Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Contact Person    44-117-342-0205      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD    44-1223-348-151      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD    44-113-206-4984    adam.glaser@leedsth.nhs.uk   
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD    44-116-258-5309    johannes.visser@uhl-tr.nhs.uk   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Contact Person    44-151-252-5294      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Contact Person    44-20-7829-7924      
University College Hospital Recruiting
London, England, United Kingdom, NW1 2BU
Contact: Contact Person    44-20-7380-9950      
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227    bernadette.brennan@cmmc.nhs.uk   
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Contact Person    44-113-206-4985      
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Contact Person    44-115-823-0620      
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Contact Person    44-1865-234-205      
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Contact Person    44-114-271-7366      
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person    44-2380-794-101      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3455      
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD    44-289-063-3631    anthonymcarthy@royalhospital.n.i.nhs.uk   
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Veronica Neefjes    44-1224-550-217      
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD    44-29-2074-2285    heidi.traunecker@cardiffandvale.wales.nhs.uk   
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: Simon Bailey, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00514397     History of Changes
Other Study ID Numbers: CCLG-CNS-2007-04, CDR0000560114, EU-20746, EUDRACT-2007-001768-60
Study First Received: August 8, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Astrocytoma
Temozolomide
Dacarbazine
Motexafin gadolinium
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 22, 2014