Status:
TERMINATED
Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Thrombocytopenia
Eligibility:
All Genders
18-120 years
Brief 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 p...
Detailed Description
OBJECTIVES: * Compare the pharmacokinetic (PK) profiles of temozolomide (TMZ) in patients who develop severe thrombocytopenia vs PK profiles in patients who do not develop severe thrombocytopenia whi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 11 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 18 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00471653
Start Date
November 11 2006
End Date
August 18 2009
Last Update
July 9 2018
Active Locations (2)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410