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


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma

Outcome Time Frame:

After all subjects have been enrolled

Safety Issue:

Yes

Principal Investigator

Dmitri D. Kharkevitch, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Vical

Authority:

United States: Food and Drug Administration

Study ID:

IM01-101

NCT ID:

NCT00223899

Start Date:

July 2005

Completion Date:

October 2008

Related Keywords:

  • Metastatic Melanoma
  • Melanoma
  • Electroporation
  • IL-2
  • Melanoma

Name

Location

Location #2Mobile, Alabama  36606
Location #3Denver, Colorado  80045
Location #1Chicago, Illinois  60068
Location #4Montclair, New Jersey  07042