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

Vical

Status and phase: Completed; Phase 1

Conditions: Metastatic Melanoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00223899

IM01-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

A

Experimental group

Description:

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).

Treatment:

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