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Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma

NCT00277017 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-09-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

5-Flourouracil, Interferon-a, IL-2 and Thalidomide

Patients will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a max 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.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Fa-Chyi Lee, MD · University of New Mexico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2005-08-31
Completion
2005-08-31

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 NCT00277017 on ClinicalTrials.gov