14
Participants
Start Date
May 1, 2000
Primary Completion Date
September 17, 2002
Study Completion Date
October 9, 2002
autologous tumor cells plus GM-CSF-in Adjuvant
"Autologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.~Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods."
University of Virginia, Charlottesville
Craig L Slingluff, Jr
OTHER