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

Phase 2

Completed

• Conditions: Liver; Cancer
• Interventions: Drug: Thalidomide, alpha interferon; Drug: Thalidomide, interferon, Octreotide

• Registration Number: NCT00250796
• Lead Sponsor: University of New Mexico

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-08
• Primary Completion: 2006-01
• Study Completion: 2006-03
• Status Verified: 2009-12
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Thalidomide, alpha interferon	Thalidomide+alpha interferon
Arm 2	Thalidomide, interferon, Octreotide	Thalidomide+interferon+Octreotide

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

New Mexico Cancer Care Associates; 🇺🇸 Santa Fe, New Mexico, United States