Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00281905|
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 25, 2006
Last Update Posted : September 20, 2013
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Neuroblastoma||Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: methotrexate Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
- Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
- Determine the event-free survival and overall survival in children treated with this regimen.
- Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
- Determine the quality of life in children treated with this regimen.
- Determine the tolerability and long-term toxicity of this regimen in these children.
- Determine the proportion of children who require radiotherapy after treatment with this regimen.
- Determine the prognosis of children who receive both chemotherapy and radiotherapy.
- Determine the nature and behavior of brain tumors in very young children.
OUTLINE: This is a multicenter study.
- Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.
- Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.
- Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Masking:||None (Open Label)|
|Official Title:||Management of Children Aged Less Than 3 Years With Brain Tumors|
|Study Start Date :||June 1992|
- Response rate
- Event-free survival
- Local recurrence or occurrence of CNS metastases
- Quality of survival
- Long-term toxicity
- Proportion of patients requiring radiotherapy
- Prognosis of children who receive both chemotherapy and radiotherapy
- Nature and behavior of brain tumors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281905
|Our Lady's Hospital for Sick Children|
|Dublin, Ireland, 12|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Institute of Child Health at University of Bristol|
|Bristol, England, United Kingdom, BS2 8AE|
|Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Royal London Hospital|
|London, England, United Kingdom, E1 1BB|
|Great Ormond Street Hospital for Children NHS Trust|
|London, England, United Kingdom, WC1N 3JH|
|Central Manchester and Manchester Children's University Hospitals NHS Trust|
|Manchester, England, United Kingdom, M27 4HA|
|Sir James Spence Institute of Child Health|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Royal Aberdeen Children's Hospital|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Childrens Hospital for Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Richard Grundy, MD, PhD||Queen's Medical Centre|