Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to learn if lenalidomide can help to treat
uncontrolled pain caused by advanced cancer.
Primary Objectives:
1. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as
measured by the change on Edmonton symptom assessment scale (ESAS).
Secondary Objectives:
1. To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and
appetite/anorexia.
2. Determine changes in serum levels of inflammatory cytokines (IL-1beta, IL-6, TNF-alpha,
interferon(IFN)-alpha and IFN-gamma, and C-reactive protein) before and after treatment
with Lenalidomide.
3. Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
4. Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and
CD40, on myeloid and plasmacytoid dendritic cells
5. Safety (type, frequency, severity, and relationship of adverse events to study
treatment)