Clinical trial · Interventional
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
NCT00400816CI-TRIAL-00034911completedPhase 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, 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 newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.
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 Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumors | 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, 150 mg/m2/d x days 1-7 and 15-21
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Survival of Last Patient
- description
- Time in months to patient's disease progresses
Secondary outcomes (1)
- measure
- Toxicity--Count of Related Advers Events
- timeFrame
- Post-Treatment
- description
- Count of Treatment Related Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria: * Bidimensionally measurable disease * Evaluable disease * Nonevaluable disease as demonstrated by gross total surgical resection * No immediate need for cranial irradiation PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 12 weeks * Absolute granulocyte count ≥ 1,500/mm³ * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.0 times ULN * AST ≤ 3.0 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No infection requiring systemic antibiotics within the past 14 days * No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer * No unrelated medical problems that would preclude study compliance PRIOR CONCURRENT THERAPY: * No prior chemotherapy for this malignancy * No prior radiotherapy to the brain * No surgery requiring general anesthesia \> 2 hours in duration within the past 10 days * No prior temozolomide * Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry
References
Publications (0)
Data not yet available
No reference posted for this study.