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Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Not Recruiting
Trial ID: NCT00100802
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. 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.
Official Title
A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: lomustine
drug: temozolomide
radiation: radiation therapy
other: Laboratory Biomarker Analysis
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507364281