NCT00109798

Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.

Detailed description

OBJECTIVES: Primary * Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan. Secondary * 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.

Conditions

• Central Nervous System Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	temozolomide	Patient will take drug on day 1-5 of 28 day schedule
DRUG	topotecan hydrochloride	Patient will have IV on days 2-6 on a 28-day schedule

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-05-04
• Last updated: 2017-09-19