Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma

Indiana University School of Medicine

Status and phase

Terminated

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib

Drug: Lenalidomide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01348503

1004-05 IUCRO-0298;

Details and patient eligibility

About

The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical or pathological diagnosis of unresectable hepatocellular carcinoma (HCC) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study
Child-Pugh Liver Function Class A/B9
Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry
Laboratory test results within protocol-specific ranges
Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (Revlimid is only available under a restricted distribution program called "RevAssist.")
Females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study.
Able to take aspirin daily as prophylactic anticoagulation
Age >18 years at the time of signing the informed consent form
Life expectancy of at least 30 days

Exclusion criteria

No serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form
No pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
No patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study
No 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
No use of any other experimental drug or therapy within 28 days of baseline
No known hypersensitivity to thalidomide
Patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded
No prior use of lenalidomide
No concurrent use of other anti-cancer agents or treatments
No known positivity for HIV or infectious hepatitis, type B-8/9 or C
No active infection not controlled effectively with antimicrobial or antiviral therapy