Clinical trial · Interventional
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
NCT00003466CI-TRIAL-00015042completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive 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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response rate
- measure
- Activity of temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: * Astrocytoma * Oligodendroglioma * Mixed glioma * Optic pathway glioma\* * Pontine glioma\* NOTE: \*Biopsy not required * Patients with optic pathway glioma must also meet the following criteria: * Progressive loss of vision as defined by doubling of octaves * Visual acuity loss not explained by other causes * Increase in proptosis of greater than 3 mm * Increase in diameter of optic nerve of at least 2 mm on neuroimaging * Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 4 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT and SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * Creatinine less than 1.5 times ULN * BUN less than 1.5 times ULN Other: * Must be neurologically stable * No systemic disease * No acute infection requiring IV antibiotics * No frequent vomiting * No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) * No other prior or concurrent malignancies except: * Surgically cured carcinoma in situ of the cervix * Basal or squamous cell skin cancer * HIV negative * No AIDS-related illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: * At least 6 weeks since prior chemotherapy unless evidence of disease progression * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior radiotherapy unless evidence of disease progression * No concurrent radiotherapy Surgery: * At least 3 weeks since prior surgery unless evidence of disease progression * Recovered from all prior surgery Other: * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.