Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
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|ClinicalTrials.gov Identifier: NCT00109798|
Recruitment Status : Withdrawn (Sub-Investigator reloacted to another institution)
First Posted : May 4, 2005
Last Update Posted : September 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumors Lymphoma||Drug: temozolomide Drug: topotecan hydrochloride||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
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: Temodar
Drug: topotecan hydrochloride
Patient will have IV on days 2-6 on a 28-day schedule
Other Name: Topotecan
- Rate of complete radiologic response (CR) [ Time Frame: July 2006 ]
- Median overall survival [ Time Frame: July 2006 ]
- Failure-free survival [ Time Frame: July 2006 ]
- Toxicity [ Time Frame: July 2006 ]
- Overall response rate (CR and partial response) [ Time Frame: July 2006 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109798
|Study Chair:||Pamela Z. New, MD||Baylor College of Medicine|