Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hepatocellular carcinoma OR Diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis B or C Measurable disease At least 20 mm in one dimension Not amenable to curative surgical resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count greater than 1,200/mm^3 Hemoglobin at least 8.0 mg/dL Platelet count at least 25,000/mm^3 Hepatic: Bilirubin no greater than 5 mg/dL Liver function tests no greater than 5 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Regardless of fertility status: All women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study All men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study No other medical condition that would preclude study No other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy regimen No prior interferon or thalidomide for hepatocellular cancer Chemotherapy: No more than 1 prior chemotherapy regimen Other: No concurrent barbiturates or alcohol
Sites / Locations
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.