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

January 6, 2010 updated by: University of New Mexico

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Thalidomide+alpha interferon
Drug: Thalidomide, alpha interferon
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.
Experimental: Arm 2
Thalidomide+interferon+Octreotide
Drug: Thalidomide, interferon, Octreotide
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..
Other Names:
  • Sandostatin LAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
Time Frame: Disease progression and toxicity
Disease progression and toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Ian Rabinowitz, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1400C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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