A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

Phase 1

Completed

• Conditions: Metastatic Melanoma
• Interventions: Genetic: VCL-IM01 (encoding IL-2) with Electroporation

• 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	VCL-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).

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 #4; 🇺🇸 Montclair, New Jersey, United States

Location #2; 🇺🇸 Mobile, Alabama, United States

Location #3; 🇺🇸 Denver, Colorado, United States

Location #1; 🇺🇸 Chicago, Illinois, United States