Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy

• Status: Terminated
• Trial end date: 2009-08-18
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide may help doctors learn how temozolomide works in the body. It may also help doctors learn more about how a patient's genes may affect the risk of developing thrombocytopenia.

PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly diagnosed high-grade glioma receiving temozolomide and radiation therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

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