A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
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 #2 | Mobile, Alabama 36606 |
| Location #3 | Denver, Colorado 80045 |
| Location #1 | Chicago, Illinois 60068 |
| Location #4 | Montclair, New Jersey 07042 |
