| Ad Title: |
DERMA study |
| Study Title: |
A Double-blind, Randomized, Placebo-controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected Stage III Melanoma |
| Protocol Number: |
012009-030 |
| Department(s) involved in the Study: |
Surgery
|
| Purpose of the Study: |
To assess the efficacy in terms of Disease-Free Survival of the recMAGE-A3 + AS15 ASCI in the overall population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement. |
| Participant Eligibility: |
Eligible participants who are 18 or older must have histologically proven stage III B or III C cutaneous melanoma with macroscopic lymph node involvement, test positive for MAGE-A3 gene expression, be fully recovered from and disease free after surgery, have an ECOG performance status of 0-1, adequate organ function and be willing to comply with all study requirements. |
| Disease/Condition Under Study: |
Melanoma |
| Cancer Related Study: |
Yes
|
| Study Drug(s): |
Recombinant MAGE-A3 protein (RecMAGE-A3)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. James Huth |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
UT Southwestern University Hospitals St. Paul Building
|
Yes
|
|
UT Southwestern University Hospitals Zale Lipshy Building
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-1854 |
| Email: |
erica.givens@utsouthwestern.edu |
| Other Information: |
|
| Website Keywords: |
Skin Cancer
|
| Medical Keywords: |
Melanoma, Skin Cancer
|
