Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
Completed · Phase 1
Conditions studied: Melanoma (Skin), Intraocular Melanoma
In brief
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.
Key facts
- Study ID
- NCT00471133
- Run by
- Ichor Medical Systems Incorporated
- People needed
- 24
- Starts
- 2007-04-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2011-06-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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