Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005626
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-05-02
Brief Title:
Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan Camptosar CPT-11
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan Camptosar CPT-11 in Newly Diagnosed and Relapsed Indolent Lymphoproliferative Malignancies
Status:
COMPLETED
Status Verified Date:
2012-09
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have newly diagnosed or relapsed non-Hodgkins lymphoma or leukemia
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have newly diagnosed or relapsed non-Hodgkins lymphoma or leukemia
Detailed Description:
OBJECTIVES I Determine the complete and partial response rates in patients with newly diagnosed or relapsed indolent non-Hodgkins lymphoma high risk chronic lymphocytic leukemia or prolymphocytic leukemia treated with irinotecan II Determine the toxicity of this regimen in these patients III Correlate the level of DNA topoisomerase I mRNA and protein as well as SN-38 induced topoisomerase I-DNA complex formation with the clinical response and toxicity in these patients IV Determine if a down regulation of topoisomerase I or altered subcellular distribution of this enzyme is involved in the drug resistance to irinotecan
OUTLINE Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed for survival
PROJECTED ACCRUAL A total of 17-40 patients will be accrued for this study within 2 years
OUTLINE Patients receive irinotecan IV over 90 minutes on days 1 8 15 and 22 Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed for survival
PROJECTED ACCRUAL A total of 17-40 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| NCI-G00-1764 | OTHER | NCI | None |