Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
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.
Central Nervous System Tumors
Drug: topotecan hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma|
- Rate of complete radiologic response (CR) [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
- Median overall survival [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
- Failure-free survival [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: July 2006 ] [ Designated as safety issue: Yes ]
- Overall response rate (CR and partial response) [ Time Frame: July 2006 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Experimental: Temozolomide, Topotecan
Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
Patient will take drug on day 1-5 of 28 day schedule
Other Name: TemodarDrug: topotecan hydrochloride
Patient will have IV on days 2-6 on a 28-day schedule
Other Name: Topotecan
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109798
|Study Chair:||Pamela Z. New, MD||Baylor College of Medicine|