Lenalidomide (Revlimid) for the Treatment of Refractory Cancer Pain
Condition: Advanced Cancer; Pain
MeSH terms: Cancer Pain
Intervention: Lenalidomide
Intervention description: 10 mg by mouth daily
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Refractory Cancer Pain; Lenalidomide; Revlimid; CC-5103

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)
    

Eligibility 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