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Brief Title: Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma
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.
Study ID: NCT00277017
Brief 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.
Detailed 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Lovelace Sandia Health Systems Dept of Hematology, Albuquerque, New Mexico, United States
University of New Mexico, Albuquerque, New Mexico, United States
New Mexico Cancer Care Associates, Santa Fe, New Mexico, United States
Name: Fa-Chyi Lee, MD
Affiliation: University of New Mexico
Role: PRINCIPAL_INVESTIGATOR