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

Sponsor:	Vical
Information provided by:	Vical
ClinicalTrials.gov Identifier:	NCT00223899

Purpose

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	Intervention	Phase
Metastatic Melanoma	Genetic: VCL-IM01 (encoding IL-2) with Electroporation	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by Vical:

Primary Outcome Measures:

Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma [ Time Frame: After all subjects have been enrolled ] [ Designated as safety issue: Yes ]

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. [ Time Frame: After all subjects have been enrolled ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	July 2005
Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223899

Locations

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

Sponsors and Collaborators

Vical

Investigators

Study Director:

Dmitri D. Kharkevitch, MD, PhD

Vical

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Richard T. Kenney, Vical Incorporated
ClinicalTrials.gov Identifier:	NCT00223899 History of Changes
Other Study ID Numbers:	IM01-101
Study First Received:	September 13, 2005
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vical:

Melanoma
Electroporation
IL-2

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012