Melanoma (Skin) Clinical Trial
Official title:
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
RATIONALE: Vaccines made from DNA may help the body build an effective immune response to
kill tumor cells. Giving the vaccine in different ways may make a stronger immune response
and kill more tumor cells.
PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine
therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage
III, or stage IV melanoma.
OBJECTIVES:
Primary
- 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.
Secondary
- Observe patients with measurable tumor for evidence of any antitumor response generated
after vaccination.
- 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
arms.
- 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
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