Cancer Clinical Trial
Official title:
Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Primary Aim Determine the response rate and time to progression of the combination of
thalidomide, interferon, and octreotide in patients with unresectable hepatocellular
carcinoma (cancer of the liver that can't be treated surgically).
Secondary Aims
1. Determine the toxicity of this combination in this population.
2. Determine the survival of this patient cohort treated with the combination.
3. Determine the percent of patients with hepatocellular carcinoma who have a positive
octreotide scan.
The purpose of this study is to determine the response rate and time to progression of the
combination of thalidomide, alfa interferon, and octreotide (Sandostatin LAR) in patients
with unresectable hepatocellular carcinoma. If patients are eligible for and agree to take
part in the study, they will be assigned to one of two treatment arms depending on SSR
status. If SSR status is positive or unknown, patients will receive oral doses of
thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week
depending on tolerance. They will also receive injections three times a week of alpha
interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks
muscle..
If the patient SSR status is negative, patients will not be given subcutaneous injections of
octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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