Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Condition: Anaplastic Astrocytoma; Central Nervous System Neoplasm; Glioblastoma; Gliosarcoma; Spinal Cord Neoplasm
MeSH terms: Neoplasms; Glioblastoma; Astrocytoma; Gliosarcoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying how well giving radiation therapy together with temozolomide
      and lomustine works in treating young patients with newly diagnosed gliomas. Radiation
      therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as
      temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving radiation therapy together
      with temozolomide and lomustine after surgery may kill any remaining tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas
      treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine
      with historical controls.

      II. Determine the toxicity of this regimen in these patients. III. Correlate MGMT and p53
      expression in tumor tissue with outcome in patients treated with this regimen.

      IV. Correlate polymorphisms in GSTP1, GSTM1 and GSTT1 genes and GSTP1 protein expression in
      tumors with survival in patients treated with this regimen.

      OUTLINE: This is a pilot, multicenter study.

      CHEMORADIOTHERAPY: Patients receive oral temozolomide once daily on days 1-42. Patients also
      undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40.
      Patients who did not undergo prior gross total resection also undergo boost radiotherapy once
      daily on days 43-47.

      MAINTENANCE CHEMOTHERAPY: Four weeks after completion of chemoradiotherapy, patients receive
      oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every
      42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 1 year, every 6 months for 3 years and then annually
      thereafter.
    

Intervention name(s): Laboratory Biomarker Analysis; Lomustine; Radiation Therapy; Temozolomide
Intervention type(s): Other; Drug; Radiation; Drug
Intervention description(s): Correlative studies; Given PO; Undergo radiation therapy; Given PO
Other intervention name(s): 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea; 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-; Belustin; Belustine; CCNU; Cecenu; CeeNU; Chloroethylcyclohexylnitrosourea; Citostal; Gleostine; Lomeblastin; Lomustinum; Lucostin; Lucostine; N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea; Prava; RB-1509; WR-139017; Cancer Radiotherapy; ENERGY_TYPE; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation; CCRG-81045; Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-; M & B 39831; M and B 39831; Methazolastone; RP-46161; SCH 52365; Temcad; Temodal; Temodar; Temomedac; TMZ
Intervention MeSH terms: Temozolomide; Lomustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment