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Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain

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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
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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. 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)

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)
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the Treatment of Refractory Cancer Pain
Study Start Date : May 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lenalidomide
10 mg by mouth daily
Drug: Lenalidomide
10 mg by mouth daily
Other Names:
  • Revlimid
  • CC-5103




Primary Outcome Measures :
  1. 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."



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Pain intensity score of 5 or greater on Edmonton Symptom Assessment scale.
  3. Understand and voluntarily sign an informed consent form.
  4. Age >/=18 years at the time of signing the informed consent form.
  5. Able to adhere to the study visit schedule and other protocol requirements.
  6. 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.
  7. Will consent to the use of asprin (81 or 325 mg) or Low molecular weight heparin (if intolerant to to asprin)
  8. 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.
  9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  10. 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).
  11. 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.
  12. 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.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. 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.
  4. Use of any other experimental drug or therapy within 28 days of baseline.
  5. Known hypersensitivity to thalidomide.
  6. A history of development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. 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.
  9. Known positive for HIV or infectious hepatitis, type A, B or C.
  10. Patients with known myeloid malignancy or tumors having bone marrow involvement.
  11. History of alcohol abuse as determined by the CAGE questionnaire (> / = 2/4).
  12. Individual with clinically evident impaired cognition.
  13. 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.
  14. All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684242


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Sriram Yennurajalingam, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00684242     History of Changes
Other Study ID Numbers: 2006-0750
First Posted: May 26, 2008    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Refractory Cancer Pain
Lenalidomide
Revlimid
CC-5103

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents