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

Sponsor

Vical (Industry)

Overall Status

Completed

CT.gov ID

NCT00223899

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Genetic: VCL-IM01 (encoding IL-2) with Electroporation	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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).	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).

Arm

Intervention/Treatment

Experimental: A

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).

Genetic: VCL-IM01 (encoding IL-2) with Electroporation

Outcome Measures

Primary Outcome Measures

Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma [After all subjects have been enrolled]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Location #2	Mobile	Alabama	United States	36606
2	Location #3	Denver	Colorado	United States	80045
3	Location #1	Chicago	Illinois	United States	60068
4	Location #4	Montclair	New Jersey	United States	07042