Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Lymphoma Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Lymphoma
• Nervous System Neoplasms

• NCT number: NCT00109798
• Study type: Interventional
• Source: The Methodist Hospital System
• Status: Withdrawn
• Phase: N/A
• Start date: March 2005
• Completion date: July 2006