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A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver

NCT00582400 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-02-19

Study results available
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Summary

The purpose of this study is: evaluate the safety and activity of administering arsenic trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to evaluate the qualitative and quantitative toxicities of this treatment, and to measure the response to treatment and the patterns of failure and survival. The primary response measurements will be the achievement of an objective tumor response, response duration and progression-free survival

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

arsenic trioxide

Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications. The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Avi B. Markowitz, MD · University of Texas Medical Branch at Galveston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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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 NCT00582400 on ClinicalTrials.gov