Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
- Determine the complete radiologic response rate in patients with primary CNS lymphoma
treated with salvage chemotherapy comprising temozolomide and topotecan.
- Determine the median and failure-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oral temozolomide once daily on days 1-5 and topotecan IV over 30 minutes
once daily on days 2-6. Treatment repeats every 28 days for 6-8 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 6-25 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of complete radiologic response (CR)
Pamela Z. New, MD
Baylor College of Medicine
United States: Food and Drug Administration