Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000560114 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20746 | |||
| EUDRACT-2007-001768-60 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Secondary
OUTLINE: This is a multicenter study.
Patients without evidence of disease progression proceed to maintenance therapy beginning at least 4 weeks after completion of radiotherapy.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motexafin gadolinium | Drug | |||
| temozolomide | Drug | |||
| adjuvant therapy | Procedure | |||
| quality-of-life assessment | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity, steroid usage, and radiological response | ||
| Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria |
Not provided
DISEASE CHARACTERISTICS:
Inclusion criteria:
Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI
Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon Bailey, MD | Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Recruiting | Dublin | 12 | Ireland |
Not provided
Not provided
Not provided
Not provided
Not provided
| Birmingham Children's Hospital | Recruiting | Birmingham | England | B4 6NH | United Kingdom |
|
| Bristol Royal Hospital for Children | Recruiting | Bristol | England | BS2 8AE | United Kingdom |
|
| Addenbrooke's Hospital | Recruiting | Cambridge | England | CB2 2QQ | United Kingdom |
|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
|
| Leicester Royal Infirmary | Recruiting | Leicester | England | LE1 5WW | United Kingdom |
|
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting | Liverpool | England | L12 2AP | United Kingdom |
|
| University College Hospital | Recruiting | London | England | NW1 2BU | United Kingdom |
|
| Great Ormond Street Hospital for Children | Recruiting | London | England | WC1N 3JH | United Kingdom |
|
| Royal Manchester Children's Hospital | Recruiting | Manchester | England | M27 4HA | United Kingdom |
|
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
|
| Queen's Medical Centre | Recruiting | Nottingham | England | NG7 2UH | United Kingdom |
|
| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DU | United Kingdom |
|
| Children's Hospital - Sheffield | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
|
| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| Royal Belfast Hospital for Sick Children | Recruiting | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
|
| Royal Aberdeen Children's Hospital | Recruiting | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Edinburgh | Scotland | EH9 1LF | United Kingdom |
|
| Royal Hospital for Sick Children | Recruiting | Glasgow | Scotland | G3 8SJ | United Kingdom |
|
| Childrens Hospital for Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
|
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
| D000077204 | Temozolomide |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided