Metastatic Melanoma
Conditions
Keywords
Melanoma, Electroporation, IL-2
Brief summary
To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.
Detailed description
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s). Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks. Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.
Interventions
GENETICVCL-IM01 (encoding IL-2) with Electroporation
IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
Sponsors
Vical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Key criteria include: * Confirmed recurrent metastatic melanoma * Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment * Able to carry out normal daily activities and light work without assistance * Not currently receiving chemotherapy or immunotherapy * Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed) * Able and willing to give informed consent.
Exclusion criteria
- Key criteria include: * History of brain tumors (resected or stereotactically treated is allowed) * History of liver tumors * Subjects whose melanoma can be cured by surgery * Pregnant * Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma | After all subjects have been enrolled |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2. | After all subjects have been enrolled |
Countries
United States
Outcome results
None listed