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Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain

NCT00684242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-01-28

Study results available
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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)

Conditions

Interventions

DRUG

Lenalidomide

10 mg by mouth daily

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sriram Yennurajalingam, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00684242 on ClinicalTrials.gov