Trial Search Results

Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

RATIONALE: 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.

PURPOSE: 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: lomustine
  • Drug: temozolomide
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy

Phase:

Phase 2

Eligibility


DISEASE CHARACTERISTICS:

   - 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

PATIENT CHARACTERISTICS:

Age

   - 3 to 21

Performance status

   - Karnofsky 50-100% (for patients > 16 years of age)

   - Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

   - At least 8 weeks

Hematopoietic

   - Absolute neutrophil count ≥ 1,000/mm^3

   - Platelet count ≥ 100,000/mm^3 (transfusion independent)

   - Hemoglobin ≥ 8 g/dL (transfusions allowed)

Hepatic

   - Bilirubin ≤ 1.5 times upper limit of normal (ULN)

   - ALT ≤ 2.5 times ULN

   - Albumin ≥ 2 g/dL

Renal

   - Creatinine ≤ 1.5 times ULN OR

   - Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of
   normal

Pulmonary

   - No evidence of dyspnea at rest

   - No exercise intolerance

   - Pulse oximetry ≥ 94% (if determination is clinically indicated)

Other

   - 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

   - No prior biologic agents

Chemotherapy

   - No prior chemotherapy

Endocrine therapy

   - Prior corticosteroids allowed

   - No concurrent corticosteroids as an antiemetic

   - Concurrent corticosteroids allowed only for treatment of increased intracranial
   pressure

Radiotherapy

   - No concurrent radiotherapy using cobalt-60

Surgery

   - See Disease Characteristics

Other

   - No other prior treatment

   - No concurrent phenobarbital or cimetidine

   - No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
   study chemoradiotherapy

Ages Eligible for Study

3 Years - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Min Wang
6507364281
Not Recruiting