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

Metastatic Melanoma Clinical Trial

Official title:

A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223899
• Other study ID #: IM01-101
• Status: Completed
• Phase: Phase 1
• Start date: July 2005
• Est. completion date: October 2008

Study information

• Verified date: February 2019
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Genetic:
• 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).

Locations

Country	Name	City	State
United States	Location #1	Chicago	Illinois
United States	Location #3	Denver	Colorado
United States	Location #2	Mobile	Alabama
United States	Location #4	Montclair	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma		After all subjects have been enrolled
Secondary	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

External Links

•   Link