A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
- 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
- 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
PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response will be assessed clinically, cytologically, and radiographically.
Every 6 weeks
Thomas H. Davis, MD
Norris Cotton Cancer Center
United States: Data and Safety Monitoring Board
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|