Clinical trial · Interventional
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
NCT00003464CI-TRIAL-00010878completedPhase 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: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy * At least 1 bidimensionally measurable lesion PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1500/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: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * Must be neurologically stable * No systemic disease * No acute infection requiring intravenous antibiotics * No frequent vomiting * No other medical condition that would interfere with oral medication intake such as partial bowel obstruction * No prior or concurrent malignancies except: * Surgically cured carcinoma in situ of the cervix * Basal or squamous cell carcinoma of the skin * HIV negative * No AIDS-related illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: * No prior radiation therapy * No prior interstitial brachytherapy * No prior radiosurgery to the brain * Not requiring immediate radiation therapy * No concurrent radiotherapy Surgery: * Recovered from any effects of prior surgery * At least 2 weeks since prior surgical resection Other: * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.