Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436618
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2007-02-15
Brief Title:
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Trial of Everolimus RAD001 in RelapsedRefractory Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-10
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 Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
PURPOSE This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment
PURPOSE This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment
Detailed Description:
OBJECTIVES
Primary
Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin lymphoma closed to accrual as of 81808 aggressive non-Hodgkins lymphoma closed to accrual as of 2708 except for diffuse large B cell lymphoma grade III follicular lymphoma or transformed lymphoma or uncommon lymphoma closed to accrual as of 9208 including Hodgkins lymphoma treated with everolimus
Secondary
Evaluate overall survival progression-free survival and time to disease progression in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology aggressive lymphoma closed to accrual as of 2708 except for diffuse large B cell lymphoma grade III follicular lymphoma or transformed lymphoma vs indolent lymphoma closed to accrual as of 81808 vs uncommon lymphoma closed to accrual as of 9208
Patient receive oral everolimus daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma
After completion of study treatment patients are followed periodically for up to 5 years
Primary
Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin lymphoma closed to accrual as of 81808 aggressive non-Hodgkins lymphoma closed to accrual as of 2708 except for diffuse large B cell lymphoma grade III follicular lymphoma or transformed lymphoma or uncommon lymphoma closed to accrual as of 9208 including Hodgkins lymphoma treated with everolimus
Secondary
Evaluate overall survival progression-free survival and time to disease progression in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to histology aggressive lymphoma closed to accrual as of 2708 except for diffuse large B cell lymphoma grade III follicular lymphoma or transformed lymphoma vs indolent lymphoma closed to accrual as of 81808 vs uncommon lymphoma closed to accrual as of 9208
Patient receive oral everolimus daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma
After completion of study treatment patients are followed periodically for up to 5 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 |
|---|---|---|---|
| MC048G | OTHER | None | None |
| 1042-05 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |