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Clinical Trial Summary

The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already established treatment regimen.


Clinical Trial Description

Eligible patients who agree to take part in the study will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a maximum of 1200mg/day. This will be taken in combination with:

5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.

Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks.

Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.

Treatment will be followed by 2 weeks of rest then repeated. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00277017
Study type Interventional
Source New Mexico Cancer Care Alliance
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2000
Completion date August 2005

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