A Dose Ranging Trial of Adenovirus CCL-21 Transduced MART-1/gp100 Peptide-Pulsed Dendritic Cells Matured Using Cytokines for Patients With Chemotherapy-Resistant Metastatic Melanoma
In this phase I study, patients will receive intradermal injections of adenovirus-CCL-21
transduced class I peptide-pulsed DC with total volumes for each intradermal injection of no
more than 1 ml to be split into four injections of 0.25 ml each in four limbs in node
draining areas (proximal arms and thighs), for a total DC dose of 2 X 10^6, 10^7 or 2 X 10^7
cells to be administered intradermally. DC injections in one course of therapy will be given
four times at intervals of weekly for two doses (days 1 and 8 +/- 72 hrs.), then every two
weeks for two doses (at days 22 +/- 72 hrs. and 36 +/- 72 hours). Cells will be harvested
for DC administration and a flow cytometry analysis as well as microbiologic analysis
including bacterial/fungal cultures and gram stain will be performed prior to infusion. All
injections will be based on number of DC, not number of total cells.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Immune response
Assessment of immune responses to the cytokine-cocktail-matured class I peptide-pulsed adenoviral CCL-21 transduced DC cell vaccine. Immune reactivity will be monitored for the appearance of lymphoid-like structures at the vaccine site (as a result of CCL-21 production), in the blood for MART-1 /gp100 specific T cell frequency by tetramer based flow cytometry and ELISPOT analysis of fresh cells, and CTL cytolytic reactivity after in vitro sensitization prior to, four weeks after, and 8 weeks after immunization.
2 years, 5 months
No
Jeffrey S. Weber, MD, PhD
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC-15280
NCT00798629
November 2008
April 2012
Name | Location |
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H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |