Injection of AJCC Stage IIB, IIC, III, and IV Melanoma Patients With Human and Mouse gp100 DNA: A Phase I Trial to Assess Safety and Immune Response
- Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in
patients with stage IIB, IIC, III, or IV melanoma.
- Determine the maximum tolerated dose of this regimen in these patients.
- Compare the antibody and T-cell response in patients treated with two different
- Assess antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1,
4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and
- Arm II: Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients
then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16.
In both arms, treatment continues in the absence of disease progression or unacceptable
Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and
mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 9 patients experience dose-limiting
After completion of study treatment, patients are followed at 3 weeks and then annually for
PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and feasibility
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|