A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
- Conditions
- Metastatic Melanoma
- Registration Number
- NCT00223899
- Lead Sponsor
- Vical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma After all subjects have been enrolled
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Location #2
🇺🇸Mobile, Alabama, United States
Location #3
🇺🇸Denver, Colorado, United States
Location #1
🇺🇸Chicago, Illinois, United States
Location #4
🇺🇸Montclair, New Jersey, United States
Location #2🇺🇸Mobile, Alabama, United States