Clinical trial · Interventional
Temozolomide in Treating Patients With Low-Grade Glioma
A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
NCT00313729CI-TRIAL-00036980completedPhase 2Results postedClinicalTrials.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)
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. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Tumor, Adult | Adult Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- Temozolomide
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- Response Rate (Complete and Partial Response)
- timeFrame
- 12 months
- description
- Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
Secondary outcomes (2)
- measure
- Time to Tumor Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: * Oligodendroglioma * Astrocytoma * Oligoastrocytoma * Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy * Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * BUN \< 1.5 times ULN * Bilirubin \< 1.5 times ULN * SGOT \< 2.5 times ULN * Alkaline phosphatase \< 2 times ULN * Life expectancy \> 12 weeks * No nonmalignant systemic disease resulting in the patient being a poor medical risk * No acute infection requiring intravenous antibiotics * No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) * No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * Prior malignancies must be in remission for ≥ 5 years * No known HIV positivity * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma * No prior biological therapy or chemotherapy for low-grade glioma * No other concurrent chemotherapy * No concurrent radiotherapy or biological therapy * No concurrent prophylactic growth factors * No concurrent epoetin alfa * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.