Cancer Clinical Trial
Official title:
A Phase I/II Trial of Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, and Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma.
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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