Intradermal naked DNA vaccination for mounting tumor-specific immunity in stage IV melanoma patients: a phase I clinical study
- Conditions
- melanomaskin cancer10027476
- Registration Number
- NL-OMON35508
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• 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 < 1.5 x ULN, normal blood coagulation)
• Willing and able to undergo the planned study procedures
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>1.) Dose limiting toxicity of intradermal DNA vaccination using a plasmid<br /><br>encoding tetanus toxin fragment c and an immunodominant HLA-A2 binding MART-1<br /><br>peptide.<br /><br>2.) Unacceptable toxicity of the use of a new device for intradermal delivery<br /><br>of plasmid DNA. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1.) Immunological response against MART-1 in blood and biopsy material<br /><br>2.) Objective clinical responses according RECIST</p><br>