Clinical Trials Directory

Trials / Completed

CompletedNCT01075321

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

A Phase I/II Clinical Trial of the mTor Inhibitor RAD001 (Everolimus) in Combination With Lenalidomide (Revlimid) for Patients With Relapsed or Refractory Lymphoid Malignancy

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVES: I.Phase I: To establish the maximum tolerated dose of EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. II. Phase II: To assess tumor response to EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. SECONDARY OBJECTIVES: I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving EVEROLIMUS and lenalidomide. II. To describe the adverse event profile (using CTCAE CTEP Version 4.0) of EVEROLIMUS and lenalidomide. OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Conditions

Interventions

TypeNameDescription
DRUGeverolimusGiven orally
DRUGlenalidomideGiven orally
OTHERlaboratory biomarker analysisCorrelative studies
GENETICpolymorphism analysisCorrelative studies
OTHERimmunohistochemistry staining methodOptional correlative studies
GENETICmicroarray analysisOptional correlative studies
GENETICfluorescence in situ hybridizationOptional correlative studies

Timeline

Start date
2011-01-10
Primary completion
2015-02-28
Completion
2020-02-13
First posted
2010-02-25
Last updated
2020-10-22
Results posted
2020-03-23

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01075321. Inclusion in this directory is not an endorsement.