MedTrace Logo

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

NCT00250796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-01-07

No results posted yet for this study

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.

Conditions

Interventions

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.

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..

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Ian Rabinowitz, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2006-01-31
Completion
2006-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00250796 on ClinicalTrials.gov