Clinical trial · Interventional
Prolonged Daily Temozolomide for Low-Grade Glioma
A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma
NCT00165360CI-TRIAL-00002750completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Oligodendroglioma | Oligodendroglioma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the effects temozolomide has on low-grade gliomas
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- To determine whether temozolomide is effective in preventing or delaying future tumor growth
- timeFrame
- 3 years
- measure
- to determine the safety of temozolomide
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) * Measurable disease on MRI * Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery. * Patients with recurrent disease my have had one prior chemotherapy regimen * Older than 18 years of age. * Karnofsky performance status (KPS) performance score of \> 70% * Adequate hematologic, renal and liver functions, * Life expectancy of greater than 12 weeks. * Negative pregnancy test. Exclusion Criteria: * Prior treatment with temozolomide * Patients who are not neurologically stable * Acute infection treated with intravenous antibiotics * Non-malignant systemic disease * Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication. * Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin. * HIV positive or AIDS-related illness * Pregnant or nursing women * Patients with allergy to decarbazine.
References
Publications (0)
Data not yet available
No reference posted for this study.