Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain
|ClinicalTrials.gov Identifier: NCT00684242|
Recruitment Status : Terminated (Low accrual.)
First Posted : May 26, 2008
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer.
1. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS).
- To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and appetite/anorexia.
- 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.
- Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
- Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and CD40, on myeloid and plasmacytoid dendritic cells
- Safety (type, frequency, severity, and relationship of adverse events to study treatment)
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Pain||Drug: Lenalidomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the Treatment of Refractory Cancer Pain|
|Study Start Date :||May 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
10 mg by mouth daily
10 mg by mouth daily
- Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: From baseline to Day 15 ]Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 "no symptom" to 10 "worst possible symptom."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684242
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sriram Yennurajalingam, MD||M.D. Anderson Cancer Center|