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Sponsored by: |
Vical |
Information provided by: | Vical |
ClinicalTrials.gov Identifier: | NCT00223899 |
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 |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | Sodium chloride |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | July 2005 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
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).
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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).
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria - Key criteria include:
Exclusion Criteria - Key criteria include:
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 |
Vical |
Study Director: | Bill Paxton, MD | Vical |
Related Info 
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Responsible Party: | Vical Incorporated ( Robin Jackman, Senior Vice President ) |
Study ID Numbers: | IM01-101 |
First Received: | September 13, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00223899 |
Health Authority: | United States: Food and Drug Administration |
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