Temozolomide in Treating Patients With Brain Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the activity of temozolomide in patients with brain metastases. Determine the toxicity of this treatment in these patients. OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other). Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

Official Title
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Phase II Treatment of Adults With Brain Metastases With Temodar

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult tumors metastatic to brain