Clinical trial · Observational
Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy
A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comparative genomic hybridization | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by Area Under the Curve (AUC)
- timeFrame
- Day 1, Day 22, Day 43
- description
- 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.
- measure
- Pharmacokinetics (PK) of temozolomide (TMZ) in patients with severe thrombocytopenia after standard first-line therapy as measured by maximum drug concentration (Cmax)
- timeFrame
- Day 1, Day 22, Day 43
- description
- Cmax in patients who develop severe thrombocytopenia after receiving standard first-line therapy of temozolomide (TMZ) for management of newly diagnosed high-grade gliomas.
- measure
- Pharmacokinetic (PK) profile of temozolomide (TMZ) in patients without severe thrombocytopenia after standard first-line therapy as measured by AUC
- timeFrame
- Day 1, Day 22, Day 43
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available