Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003245
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkins Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkins lymphoma
OUTLINE Patients are stratified by disease category aggressive vs indolent vs mantle cell lymphoma Patients with aggressive and indolent lymphoma are further stratified as to being refractory no complete response CR or partial response PR to initial therapy vs recurrent CR or PR to initial therapy ie the following subcategories are used
Stratum IRefractory aggressive non-Hodgkins lymphoma NHL
Stratum IIRecurrent aggressive NHL
Stratum III Refractory indolent NHL
Stratum IV Recurrent indolent NHL
Stratum V Mantle cell NHL All patients receive irinotecan intravenously every 21 days Patients achieving CR or PR receive 6 courses Patients may receive bone marrow transplantation after at least 2 courses
Patients are followed every 3 months for survival
PROJECTED ACCRUAL This study will accrue 18 patients per stratum if at least three patients respond an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum The total number accrued will be 90-215 over a period of approximately 3 years
Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkins lymphoma
OUTLINE Patients are stratified by disease category aggressive vs indolent vs mantle cell lymphoma Patients with aggressive and indolent lymphoma are further stratified as to being refractory no complete response CR or partial response PR to initial therapy vs recurrent CR or PR to initial therapy ie the following subcategories are used
Stratum IRefractory aggressive non-Hodgkins lymphoma NHL
Stratum IIRecurrent aggressive NHL
Stratum III Refractory indolent NHL
Stratum IV Recurrent indolent NHL
Stratum V Mantle cell NHL All patients receive irinotecan intravenously every 21 days Patients achieving CR or PR receive 6 courses Patients may receive bone marrow transplantation after at least 2 courses
Patients are followed every 3 months for survival
PROJECTED ACCRUAL This study will accrue 18 patients per stratum if at least three patients respond an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum The total number accrued will be 90-215 over a period of approximately 3 years
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 |
|---|---|---|---|
| DM97-182 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-97182 | None | None | None |
| NCI-T97-0103 | None | None | None |