Phase II Intratumoral IL12 Plasmid Electroporation in Cutaneous Lymphoma
Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
A single arm, open label, multi-center, phase 2 study to assess the safety and anti-tumor
activity of intratumoral IL-12 plasmid (i.e., pIL-12) electroporation in subjects with stage
IB to IIIB mycosis fungoides.
All subjects may receive up to six cycles of treatment consisting of two treatment days,
Days 1 and 8, in a 28-day cycle. Patients will receive intra-tumoral injection of pIL-12 at
a concentration of 0.5mg/ml and a fixed volume of 0.25 mL per each 1.0 cm diameter of target
region, followed immediately by electrical discharge around the tumor site resulting in
electroporation of plasmid DNA into tumor cells.