Clinical trial · Interventional
Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors
A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Collecting fluid samples through a catheter may help doctors find out how well temozolomide spreads throughout the brain. PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain tumors or metastatic brain tumors.
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 | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| liquid chromatography | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Incidence rate of clinically symptomatic intratumoral hemorrhage
- measure
- Incidence rate of CNS infection
- measure
- Incidence rate of catheter malfunction
Secondary outcomes (1)
- measure
- Systemic and intracerebral pharmacokinetic profile of temozolomide using a microdialysis catheter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of a primary or metastatic brain tumor for which temozolomide would be an appropriate chemotherapy treatment postoperatively * Disease requires a debulking craniotomy or a stereotactic biopsy to diagnose or differentiate between tumor progression and treatment-induced effects after radiotherapy with or without chemotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 2.0 mg/dL * AST ≤ 4 times upper limit of normal (ULN) * Creatinine ≤ 1.5 time ULN * Mini Mental Status Exam score ≥ 15 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to temozolomide * No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No concurrent chemotherapy or radiotherapy during the period of time that the microdialysis catheter is placed intracerebrally and until it is removed
References
Publications (0)
Data not yet available