RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
OBJECTIVES: * Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide. * Determine adverse events related to this regimen in this patient population. * Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients. OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response. Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter. PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Objective Response
Response will be assessed clinically, cytologically, and radiographically.
Time frame: Every 6 weeks
Pharmacokinetics
Drug levels in cerebrospinal fluid assessed every 6 weeks
Time frame: Every 6 weeks
Survival
Time frame: every 6 weeks
Quality of Life
FACT-Br
Time frame: Baseline, weekly during cycle 1, before each additional cycle
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