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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Interferon-alfa-1b; Interferon-alpha; Interferons; Octreotide; Thalidomide

Criteria

Inclusion Criteria:

1. Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml

2. The tumor is unresectable

3. Performance status of < 2.0

4. > 18 years of age

5. Informed consent to be signed by patient

6. No previous treatment with thalidomide, alpha interferon, or octreotide

7. The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.

8. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.

9. The patient must have measurable disease.

10. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.

11. Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K

12. Patients may not have symptomatic cholelithiasis.

Exclusion Criteria: