Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109798
Status:
WITHDRAWN
Last Update Posted:
2017-09-19
First Post:
2005-05-03
Brief Title:
Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sub-Investigator reloacted to another institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000427313 | OTHER | Principal Investigator | None |