NCT00912418

Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) - in - Adjuvant, Followed by Systemic Low-dose-interleukin-2 (IL-2) Administration, in Patients With High Risk Melanoma

Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus GM-CSF-in-adjuvant, Followed by Systemic Low-dose-IL-2 Administration, in Patients With High Risk Melanoma.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, pilot study of an autologous tumor cell vaccine.

Detailed description

Regimen: A vaccine comprising autologous melanoma cells plus GM-CSF in-adjuvant will be administered intradermally at a single dose. 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2000-05-01
• Primary completion: 2002-09-17
• Completion: 2002-10-09
• First posted: 2009-06-03
• Last updated: 2020-03-02

Locations

1 site across 1 country: United States