A Pilot Clinical Trial of Lenalidomide (Revlimid®) for the Treatment of Refractory Cancer Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)
Study Overview
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:
- Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS).
Secondary Objectives:
- 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)
Detailed Description
The Study Drug:
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. The drug is also designed to decrease the level of certain proteins in the blood called cytokines, which may result in decreased pain.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide capsules each morning, with or without food. Take lenalidomide capsules whole, with a 4-ounce (1/2 cup) glass of water at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
If you take too much lenalidomide, call your study doctor or health care provider or poison control center right away.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Lenalidomide
10 mg by mouth daily
Intervention: Lenalidomide (Drug)
Outcomes
Primary Outcomes
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."
Secondary Outcomes
No secondary outcomes reported