melanoma
Conditions
Interventions
Intervention: Intradermal DNA vaccine delivery by permanent make-up device on
days 1, 3, and 6 and boost vaccination 4 weeks later.
Sponsors
NKI-AVL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age above 18 years • Performance score: WHO 0 or 1 • Life expectancy of >= 3 months • Histologically or cytologically proven metastatic melanoma. • Expression of MART-1. • HLA-A*0201 positive. • Evaluable disease. • Disease progression after chemotherapy-based treatment. • Adequate bone marrow (WBC > 3.0/nL, platelets > 100/nL), renal function (creatinine clearance > 40 mL/min, and liver function (bilirubin
Exclusion criteria
Exclusion criteria: • Previous MART-1-specific immunotherapy. • Patients with severe cardiac, respiratory, or metabolic disease. • Symptomatic brain metastases. • Use of systemic steroids or other immunosuppressive drugs. • Use of oral anticoagulant drugs. • Other cancers, except basal cell carcinomas or cervical CIS. • Severe infections requiring antibiotics. • Lactation or pregnancy • Not willing to take adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: 1.) Dose limiting toxicity of intradermal DNA vaccination using a plasmid encoding tetanus toxin fragment c and an immunodominant HLA-A2 binding MART-1 peptide. 2.) Unacceptable toxicity of the use of a new device for intradermal delivery of plasmid DNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.) Immunological response against MART-1 in blood and biopsy material 2.) Objective clinical responses according RECIST | — |
Countries
Netherlands
Outcome results
None listed