Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00436618
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2007-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase II Trial of Everolimus (RAD001) in Relapsed/Refractory 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 8/18/08), aggressive non-Hodgkin's lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of 9/2/08), including Hodgkin's 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 \[closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma\] vs indolent lymphoma \[closed to accrual as of 8/18/08\] vs uncommon lymphoma \[closed to accrual as of 9/2/08\]).
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 8/18/08), aggressive non-Hodgkin's lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of 9/2/08), including Hodgkin's 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 \[closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma\] vs indolent lymphoma \[closed to accrual as of 8/18/08\] vs uncommon lymphoma \[closed to accrual as of 9/2/08\]).
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| MC048G | OTHER | Mayo Clinic Cancer Cancer | View | |
| 1042-05 | OTHER | Mayo Clinic IRB | View |