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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VCL-IM01 (encoding IL-2) with Electroporation

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, Electroporation, IL-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Location #2
Location #3
Location #1
Location #4

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm 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).

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00223899

First Posted

September 13, 2005

Last Updated

February 25, 2019

Sponsor

Vical

1. Study Identification

Unique Protocol Identification Number

NCT00223899

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vical

4. Oversight

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Melanoma

Keywords

Melanoma, Electroporation, IL-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm 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).

Intervention Type

Genetic

Intervention Name(s)

VCL-IM01 (encoding IL-2) with Electroporation

Intervention 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).

Primary Outcome Measure Information:

Title

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

Time Frame

After all subjects have been enrolled

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dmitri D. Kharkevitch, MD, PhD

Organizational Affiliation

Vical

Official's Role

Study Director

Facility Information:

Facility Name

Location #2

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36606

Country

United States

Facility Name

Location #3

City

Denver

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Location #1

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Location #4

City

Montclair

State/Province

New Jersey

ZIP/Postal Code

07042

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.vical.com

Description

Related Info

Metastatic Melanoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial