Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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 Determine the toxicity of this combination in this population. Determine the survival of this patient cohort treated with the combination. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.

Detailed Description
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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.

Official Title
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Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma

Conditions
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Liver, Cancer

Intervention / Treatment
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* Drug: Thalidomide, alpha interferon
* Drug: Thalidomide, interferon, Octreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml The tumor is unresectable Performance status of < 2.0 > 18 years of age Informed consent to be signed by patient No previous treatment with thalidomide, alpha interferon, or octreotide The patient may have received previous chemotherapy either systemically or via the intra hepatic artery. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. The patient must have measurable disease. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K Patients may not have symptomatic cholelithiasis. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Thalidomide+alpha interferon | Drug: Thalidomide, alpha interferon<br>* 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.<br>|
| Experimental: Arm 2<br>Thalidomide+interferon+Octreotide | Drug: Thalidomide, interferon, Octreotide<br>* 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..<br>* Other names: Sandostatin LAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma. |  | Disease progression and toxicity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase II, Hepatocellular carcinoma