Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
18 Years
N/A
Both
Liver, Cancer
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 |
