Clinical trial · Interventional
A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
NCT00223899CI-TRIAL-00037309completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VCL-IM01 (encoding IL-2) with Electroporation | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- 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).
- interventionNames
- Genetic: VCL-IM01 (encoding IL-2) with Electroporation
Primary outcomes (1)
- measure
- Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
- timeFrame
- After all subjects have been enrolled
Secondary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.