Liver Cancer
Conditions
Keywords
liver cancer, second line
Brief summary
This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.
Detailed description
This study will determine the response rate and toxicities of lenalidomide as second line treatment for patients with liver cancer who have progressed after sorafenib.
Interventions
DRUGlenalidomide
25 mg po qd x 21 days then 1 week off equals one cycle
Sponsors
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate by Recist Criteria | on average about every 2 months until progression, on average about 4 months. | radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lenalidomide |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 60.5 years |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 18 / 40 |
Outcome results
Primary
Response Rate by Recist Criteria
radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.
Time frame: on average about every 2 months until progression, on average about 4 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Response Rate by Recist Criteria | 6 participants |