Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide
Verified date | July 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | August 18, 2009 |
Est. primary completion date | November 12, 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by Area Under the Curve (AUC) | AUC (mg*h/L)in patients who develop severe thrombocytopenia after receiving standard first-line therapy of temozolomide (TMZ) for management of newly diagnosed high-grade gliomas. | Day 1, Day 22, Day 43 | |
Primary | Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by maximum drug concentration (Cmax) | Cmax in patients who develop severe thrombocytopenia after receiving standard first-line therapy of temozolomide (TMZ) for management of newly diagnosed high-grade gliomas. | Day 1, Day 22, Day 43 | |
Primary | Pharmacokinetic (PK) profile of temozolomide (TMZ) in patients without severe thrombocytopenia after standard first-line therapy as measured by AUC | AUC in patients in patients who do not develop severe thrombocytopenia after receiving standard first-line therapy of TMZ for management of newly diagnosed high-grade gliomas. | Day 1, Day 22, Day 43 | |
Primary | Pharmacokinetic (PK) profile of temozolomide (TMZ) in patients without severe thrombocytopenia after standard first-line therapy as measured by Cmax | Cmax in patients in patients who do not develop severe thrombocytopenia after receiving standard first-line therapy of TMZ for management of newly diagnosed high-grade gliomas. | Day 1, Day 22, Day 43 | |
Secondary | Presence of single nucleotide polymorphisms in the O6-methylguanine-DNA methyltransferase gene. | Presence of single nucleotide polymorphisms in the O6-methylguanine-DNA methyltransferase gene of patients who develop thrombocytopenia after receiving standard first-line therapy for management of newly diagnosed high-grade gliomas. | Day 1 |
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