A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed high-grade glioma (WHO grade III or IV)

- Must be scheduled to receive standard first-line therapy (cranial radiotherapy and
temozolomide)

PATIENT CHARACTERISTICS:

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.7 mg/dL

- Bilirubin ≤ 1.5 mg/dL

- Transaminases ≤ 4 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except curatively treated carcinoma in
situ or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

- No prior hormonal therapy for brain tumor

- No prior biological agents (including immunotoxins, immunoconjugates, antisense
agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating
lymphocytes, lymphokine-activated killer cells, or gene therapy)

- No prior immunotherapy

- No prior chemotherapy

- No prior radiotherapy, including cranial radiotherapy

- Concurrent glucocorticoid therapy allowed

- No concurrent carbamazepine

- No other concurrent experimental therapy

- No other concurrent cytotoxic therapy