Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial
Condition: Liver Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Intervention: lenalidomide
Intervention description: 25 mg po qd x 21 days then 1 week off equals one cycle
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: liver cancer, second line

Summary:

      This study will determine whether lenalidomide has activity in patients with advanced liver
      cancer that have had growth of their cancer after sorafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with
             known cirrhosis and AFP > 200 ng/ml.

          2. Disease not amenable to curative surgical resection

          3. Patients must have been previously treated with sorafenib. Patients who are unable to
             receive sorafenib due to financial reasons are also eligible.

          4. All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

          5. No previous thalidomide.

          6. Patients must have radiologically assessable tumor.

          7. ECOG performance status of 0-2 at study entry.

          8. Understand and voluntarily sign an informed consent form.

          9. Age >18 years at the time of signing the informed consent form.

         10. Able to adhere to the study visit schedule and other protocol requirements.

         11. Laboratory test results within these ranges:

               -  Absolute neutrophil count > 1000/mm3

               -  Platelet count > 60,000/mm3

               -  Serum creatinine > 2.0 mg/dL

               -  Total bilirubin > 4 mg/dL

               -  AST (SGOT) and ALT (SGPT) > 5 x ULN.

         12. Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
             and again within 24 hours of starting lenalidomide 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. All patients must be
             counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal
             exposure. See Appendix: H Risks of Fetal Exposure, Pregnancy Testing Guidelines and
             Acceptable Birth Control Methods, AND also Appendix: F Education and Counseling
             Guidance Document

         13. Disease free of prior malignancies for > 2 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast

        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. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          7. Any prior use of lenalidomide.

          8. Concurrent use of other anti-cancer agents or treatments.

          9. Known positive for HIV. (The effect of immune modulation of lenalidomide on patients
             who are HIV positive is unknown).