Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00912418
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2009-06-01
Brief Title:
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
Sponsor:
Craig L Slingluff Jr
Organization:
University of Virginia
Study Overview
Official Title:
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
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEL37
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None