Durham, North Carolina 27710

  • Brain and Central Nervous System Tumors


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Henry S. Friedman, MD
Duke University

Backup Contact:


Location Contact:

Durham, North Carolina 27710
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.