A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Cutaneous Lymphoma
Patients will receive intra-tumoral injection of pIL-12 at a concentration of 1mg/ml
followed immediately by electrical discharge around the tumor site resulting in
electroporation of plasmid DNA into tumor cells. The volume of pIL12 used per treatment is
in proportion of the total volume of the skin lesions treated, which is calculated as
described in Section 6.2. The maximum volume of each treatment (including up to 4
electroporated lesions) per patient is 1 ml and the total volume of pIL12 to be injected is
not to exceed 3 ml per cycle. Patients, who do not have progressive disease at
non-electroporated sites as judged by modified SWAT or intolerability of the treatment, can
receive additional treatment every 3 months for a total of 4 cycles (12 months).
One cycle of treatment consists of three electroporations applied per lesion, to at least
two and a maximum of four lesions each day on days 1, 5 and 8 (±1 day). Prior to plasmid
injection, using sterile precautions, 1% lidocaine may be injected around the lesion to
obtain local anesthesia (prior history of lidocaine hypersensitivity will be assessed prior
to administration of local lidocaine injections).
For each cycle, previous untreated sites or previously treated sites that have evidence of
persistent disease will be selected as the new electroporation sites.
All grade 3 and 4 toxicities from previous treatments must resolve completely before
initiating a new cycle of treatment. Treatment response at untreated sites will be
evaluated according to the standard modified SWAT. Response at the electroporated sites
will be recoded separately.
Three skin biopsies will be performed during a course of 1 year of treatment. Additional
biopsies may be obtained if judged necessary by the treating physician and consented to by
After the completion of the treatment period of the trial, subjects will be followed for
survival at a 6-month interval for a period of 5 years. This follow up period starts after
the last scheduled assessment in the treatment period of the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local and distant response rate in patients treated with pIL-12
Patients who complete at least one cycle of treatment are considered evaluable for response. Clinical response will be evaluated and scored every 28 days by the modified SWAT. Confirmation of response requires a second assessment after at least 4 weeks. Progression of disease while on treatment should be confirmed by a second assessment 1-4 weeks later.
28 days from day 1 of treatment
Weiyun Ai, M.D.
University of California, San Francisco
United States: Food and Drug Administration
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