Clinical trial · Interventional
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
NCT00471133CI-TRIAL-00004950completedPhase 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)
The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TriGrid Delivery System for Intramuscular Electroporation | Device | — | UNRESOLVED |
| Xenogeneic Tyrosinase DNA Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Xenogeneic Tyrosinase
- interventionNames
- Biological: Xenogeneic Tyrosinase DNA Vaccine
- Device: TriGrid Delivery System for Intramuscular Electroporation
Primary outcomes (1)
- measure
- Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.
- timeFrame
- one year
Secondary outcomes (2)
- measure
- Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
- timeFrame
- 6 months
- measure
- Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have documented, histologically confirmed malignant melanoma, American Joint Commission on Cancer (AJCC) Stage IIB- IV. Patients with stage IIb-III disease are only eligible after standard surgical care with wide local excision and appropriate lymph node sampling. Patients with stage IIb, IIc, or III melanoma who are free of disease after surgical resection are also eligible, only if they have refused high dose Interferon-alfa (INTRON A) or have had a recurrence while on Interferon-alfa. * Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter \>16mm; Height \>8mm or involvement of the ciliary body with tumor. * Patients must be at least 18 years of age and must be capable of understanding the consent form and giving informed consent. * Karnofsky Score \> 80 * Life Expectancy \> 6 months * HLA-A1, A2, A24, or B35+ as assessed by low resolution phenotyping * White blood cell count ≥ 2,000/mm3 * Platelet count ≥ 100,000/mm3 * Neutrophil count ≥ 1,000/mm3 * Hemoglobin ≥ 9.0 g/dL * Serum AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Serum Bilirubin ≤ 2.0 mg/dL * Serum Creatinine ≤ 2.0 mg/dL * Serum Alkaline Phosphatase \< 2.5 times ULN * Serum Creatine phosphokinase (CPK) \< 2.5 times ULN Exclusion Criteria: * Documented metastases in brain * Clinical history of HIV, HepB, HepC, and/or HTLV I. * Active autoimmune disease other than vitiligo * Patients previously immunized using the tyrosinase DNA sequence, protein, or peptides. * Systemic immunosuppressive therapy (corticosteroids, or other immunosuppressive drugs) within the previous 28 days * Surgery and/or radiotherapy within the previous 28 days * Chemotherapy and/or biotherapy within the previous 28 days * Participation in an investigational study within previous 28 days * Patients with cardiac demand pacemakers. * Women who are pregnant or \< 3 months post partum or nursing. * Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study. * Any other concurrent medical condition that in the opinion of the Principal Investigator or co-Principal Investigator's would preclude study compliance.
References
Publications (1)
- DERIVEDYuan J, Ku GY, Adamow M, Mu Z, Tandon S, Hannaman D, Chapman P, Schwartz G, Carvajal R, Panageas KS, Houghton AN, Wolchok JD. Immunologic responses to xenogeneic tyrosinase DNA vaccine administered by electroporation in patients with malignant melanoma. J Immunother Cancer. 2013 Nov 18;1:20. doi: 10.1186/2051-1426-1-20. eCollection 2013. PMID 24829756