Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

Neuroblastoma Clinical Trial

Official title:

Management of Children Aged Less Than 3 Years With Brain Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00281905
• Other study ID #: CDR0000454575
• Secondary ID: CCLG-CNS-9204EU-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: September 19, 2013
• Start date: June 1992

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Brain stem tumor (histological confirmation not required)

• Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:

• Anaplastic (malignant) astrocytoma

• Glioblastoma

• Anaplastic (malignant) oligodendroglioma

• Ependymoma

• Anaplastic (malignant) ependymoma

• Anaplastic (malignant) oligoastrocytoma

• Choroid plexus carcinoma

• Astroblastoma

• Polar spongioblastoma

• Gliomatosis cerebri

• Anaplastic (malignant) ganglioglioma

• Pineoblastoma

• Mixed pineocytoma or pineoblastoma

• Medulloepithelioma

• Neuroblastoma

• Ependymoblastoma

• Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs

• Has undergone surgery or biopsy of the tumor within the past 2-4 weeks

PATIENT CHARACTERISTICS:

• No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• Prior steroids allowed

• No concurrent steroids as anti-emetics

• Concurrent steroids allowed for control of tumor-related symptoms

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms
• Neuroblastoma

Intervention

Drug:
• carboplatin

• cisplatin

• cyclophosphamide

• methotrexate

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Institute of Child Health at University of Bristol	Bristol	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children NHS Trust	London	England
United Kingdom	Royal London Hospital	London	England
United Kingdom	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England
United Kingdom	Sir James Spence Institute of Child Health	Newcastle-Upon-Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Event-free survival			No
Primary	Local recurrence or occurrence of CNS metastases			No
Primary	Quality of survival			No
Primary	Tolerance			Yes
Primary	Long-term toxicity			Yes
Primary	Proportion of patients requiring radiotherapy			No
Primary	Prognosis of children who receive both chemotherapy and radiotherapy			No
Primary	Nature and behavior of brain tumors			No