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
Intervention: Laboratory Biomarker Analysis; Lomustine; Radiation Therapy; Temozolomide
Intervention description: Correlative studies; Given PO; Undergo radiation therapy; Given PO
Intervention MeSH terms: Temozolomide; Lomustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following
             histologies:

               -  Anaplastic astrocytoma

               -  Glioblastoma multiforme

               -  Gliosarcoma

          -  Primary spinal cord malignant gliomas allowed

          -  No primary brainstem tumors

          -  Has undergone surgical resection or biopsy of the tumor within the past 31 days

               -  Pre-operative and post-operative brain MRI with and without gadolinium-contrast
                  OR pre-operative and post-operative spine MRI for spinal cord primaries

                    -  Post-operative MRI not required for patients who undergo biopsy only

          -  No evidence of neuraxis dissemination

               -  Spine MRI and cerebrospinal fluid cytology required only if clinically indicated

          -  Performance status - Karnofsky 50-100% (for patients > 16 years of age)

          -  Performance status - Lansky 50-100% (for patients ≤ 16 years of age)

          -  At least 8 weeks

          -  Absolute neutrophil count ≥ 1,000/mm^3

          -  Platelet count ≥ 100,000/mm^3 (transfusion independent)

          -  Hemoglobin ≥ 8 g/dL (transfusions allowed)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT ≤ 2.5 times ULN

          -  Albumin ≥ 2 g/dL

          -  Creatinine ≤ 1.5 times ULN

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of
             normal

          -  No evidence of dyspnea at rest

          -  No exercise intolerance

          -  Pulse oximetry ≥ 94% (if determination is clinically indicated)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 months after study
             participation

          -  Able to swallow oral medication

          -  Seizures allowed provided they are well controlled with anticonvulsants

          -  No hypersensitivity to temozolomide

          -  No prior biologic agents

          -  No prior chemotherapy

          -  Prior corticosteroids allowed

          -  No concurrent corticosteroids as an antiemetic

          -  Concurrent corticosteroids allowed only for treatment of increased intracranial
             pressure

          -  No concurrent radiotherapy using cobalt-60

          -  See Disease Characteristics

          -  No other prior treatment

          -  No concurrent phenobarbital or cimetidine

          -  No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
             study chemoradiotherapy