Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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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 Description

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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.

Conditions

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Brain and Central Nervous System Tumors

Keywords

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untreated childhood brain stem glioma

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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motexafin gadolinium

Intervention Type DRUG

temozolomide

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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

* 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

* Focal lesions of brainstem
* Predominantly exophytic tumors

PATIENT CHARACTERISTICS:

* 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:

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Simon Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Identifier Source: secondary_id

EU-20746

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-001768-60

Identifier Type: -

Identifier Source: secondary_id

CCLG-CNS-2007-04

Identifier Type: -

Identifier Source: org_study_id

Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

motexafin gadolinium

temozolomide

adjuvant therapy

quality-of-life assessment

radiation therapy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Children's Cancer and Leukaemia Group

Principal Investigators

Simon Bailey, MD

Locations

Our Lady's Hospital for Sick Children Crumlin

Birmingham Children's Hospital

Bristol Royal Hospital for Children

Addenbrooke's Hospital

Leeds Cancer Centre at St. James's University Hospital

Leicester Royal Infirmary

Royal Liverpool Children's Hospital, Alder Hey

University College Hospital

Great Ormond Street Hospital for Children

Royal Manchester Children's Hospital

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Queen's Medical Centre

Oxford Radcliffe Hospital

Children's Hospital - Sheffield

Southampton General Hospital

Royal Marsden - Surrey

Royal Belfast Hospital for Sick Children

Royal Aberdeen Children's Hospital

Royal Hospital for Sick Children

Royal Hospital for Sick Children

Childrens Hospital for Wales

Countries

Facility Contacts

Contact Person

Martin W. English, MD

Contact Person

Amos Burke, MD

Adam Glaser, MD

Johann Visser, MD

Contact Person

Contact Person

Contact Person

Bernadette Brennan, MD

Contact Person

Contact Person

Contact Person

Contact Person

Contact Person

Contact Person

Anthony McCarthy, MD

Veronica Neefjes

W. Hamish Wallace, MD

Milind D. Ronghe, MD

Heidi Traunecker, MD, PhD

Other Identifiers

CDR0000560114

EU-20746

EUDRACT-2007-001768-60

CCLG-CNS-2007-04