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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver, Cancer

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Trial Information

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


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.


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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.

Outcome Time Frame:

Disease progression and toxicity

Safety Issue:

Yes

Principal Investigator

Ian Rabinowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

1400C

NCT ID:

NCT00250796

Start Date:

September 2000

Completion Date:

March 2006

Related Keywords:

  • Liver
  • Cancer
  • Phase II
  • Hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
University of New Mexico Albuquerque, New Mexico  87131