Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse gp100 DNA: A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery
- Evaluate the safety and feasibility of particle-mediated epidermal delivery (PMED)
immunization comprising mouse gp100 plasmid DNA vaccine in patients with stage IIB,
IIC, III, or IV melanoma.
- Compare the immunologic response induced with PMED vs intramuscular jet injection
methods of vaccination in these patients.
- Observe patients with measurable tumor for evidence of any antitumor response generated
- Assess for disease relapse in patients treated with this vaccine.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive mouse gp100 plasmid DNA vaccine by particle-mediated epidermal
delivery on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.
- Arm II: Patients receive mouse gp100 plasmid DNA vaccine by intramuscular jet injection
on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.
After completion of study treatment, patients are followed periodically for 1 year.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of particle-mediated epidermal delivery (PMED) of mouse gp100 plasmid DNA vaccine
Jedd D. Wolchok, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|