Clinical trial NCT00250796: Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Official title: Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver
Cancer
Keywords: Phase II
Hepatocellular carcinoma
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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:

Primary outcomes:
measure: Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
timeFrame: Disease progression and toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Ian Rabinowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: