Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain

NCT00684242 | Terminated Phase 2 Results

• 1 other identifier: 2006-0750
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine the effect of Lenalidomide on fatigue, sleep, depressed mood, nausea and appetite/anorexia.
2. 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. 3.Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
4. 4.Effect of Lenalidomide on the expression of costimulatory receptors, CD80, CD86, and CD40, on myeloid and plasmacytoid dendritic cells
5. 5.Safety (type, frequency, severity, and relationship of adverse events to study treatment)

Conditions

Advanced Cancer; Pain

Keywords

Advanced Cancer; Refractory Cancer Pain; Lenalidomide; Revlimid; CC-5103

Outcome Measures

Primary Outcomes (1)

• Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)

  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."

  From baseline to Day 15

Study Arms (1)

Lenalidomide

EXPERIMENTAL

10 mg by mouth daily

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

10 mg by mouth daily

Also known as: Revlimid, CC-5103

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced cancer with a diagnosis of refractory cancer pain (Refractory cancer pain is defined for research purposes as the pain secondary to cancer that is refractory to strong opioids as determined by the persistence of pain despite at least 2 or more opioid escalation and/ or opioid rotations for a given pain syndrome).
• Pain intensity score of 5 or greater on Edmonton Symptom Assessment scale.
• Understand and voluntarily sign an informed consent form.
• Age \>/=18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Patients who are receiving chemotherapy are eligible for study if approved by primary oncologist. The PI or enrolling physician will obtain and document approval from the primary oncologist in the patient's study documents.
• Will consent to the use of asprin (81 or 325 mg) or Low molecular weight heparin (if intolerant to to asprin)
• Laboratory test results within these ranges within the past 14 days: Absolute neutrophil count \>/= 1.5 \* 10\^9/L , Platelet count \>/= 100 \* 10\^9/L, Serum creatinine \</= 2.0 mg/dL, Total bilirubin \</=1.5 mg/dL, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \</=2 \* Upper limit of normal (ULN) or \</= 5 \* ULN if hepatic metastases are present.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
• FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix : Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• A history of development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concomitant use of sargramostim (GM-CSF), including radiation, thalidomide, or other investigational agents is not permitted while subjects are receiving study drug during the treatment portion of the study.
• Known positive for HIV or infectious hepatitis, type A, B or C.
• Patients with known myeloid malignancy or tumors having bone marrow involvement.
• History of alcohol abuse as determined by the CAGE questionnaire (\> / = 2/4).
• Individual with clinically evident impaired cognition.
• Patient with a history of psychiatric diagnosis of depression or clinical diagnosis of depression as determined by the treating physician or Hospital Anxiety Depression Scale total score of 13 or greater.
• All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Pain; Cancer Pain

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sriram Yennurajalingam, MD / Assistant Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Sriram Yennurajalingam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 28, 2013
• Results First Posted: January 28, 2013

Record last verified: 2012-12

Locations

US (1)