Clinical trial · Interventional
Temozolomide in Treating Patients With Brain Metastases
Phase II Treatment of Adults With Brain Metastases With Temodar
NCT00005954CI-TRIAL-00010886completedPhase 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 patients who have brain metastases.
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 |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Metastatic lesions to the brain * Must not require immediate radiotherapy * If received prior radiotherapy, must have progressive disease * Evaluable disease by CT scan or MRI * Neurologically stable PATIENT CHARACTERISTICS: Age: * 18 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 or SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * Blood urea nitrogen less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent nonmalignant systemic disease * No acute infection requiring treatment with IV antibiotics * HIV negative * No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow) PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent hematopoietic growth factors, including epoetin alfa * No other concurrent biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy, unless evidence of disease progression * No other concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression * No concurrent radiotherapy Surgery: * At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.