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Status:

COMPLETED

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

Lead Sponsor:

University of New Mexico

Conditions:

Liver

Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 live...

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 h...

Eligibility Criteria

Inclusion

  • Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein \>500 ng/ ml
  • The tumor is unresectable
  • Performance status of \< 2.0
  • \> 18 years of age
  • Informed consent to be signed by patient
  • No previous treatment with thalidomide, alpha interferon, or octreotide
  • The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.
  • The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.
  • The patient must have measurable disease.
  • If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.
  • Bilirubin \<3 X ULN, AST/ALT\<3 X ULN, creat\<2, ANC\>1.5, Platelet\>75K
  • Patients may not have symptomatic cholelithiasis.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2000

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2006

    Estimated Enrollment :

    12 Patients enrolled

    Trial Details

    Trial ID

    NCT00250796

    Start Date

    September 1 2000

    End Date

    March 1 2006

    Last Update

    January 7 2010

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of New Mexico

    Albuquerque, New Mexico, United States, 87131

    2

    New Mexico Cancer Care Associates

    Santa Fe, New Mexico, United States, 87505