Injection of Renal Cell Carcinoma Patients With Human and Mouse Prostate Specific Membrane Antigen (PSMA) DNA: A Phase I Trial to Assess Safety and Immune Response
- Determine the safety and feasibility of vaccination with human and mouse
prostate-specific membrane antigen (PSMA) DNA in patients with renal cell carcinoma.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine antibody responses to human PSMA in patients treated with this regimen.
- Assess antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized, dose-escalation study. Patients are randomized to 1 of 2
- Arm I: Patients receive human prostate-specific membrane antigen (PSMA) DNA vaccine
intramuscularly (IM) once every 3 weeks for 3 doses (doses 1-3). Patients then receive
mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 4-6).
- Arm II: Patients receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses
(doses 1-3). Patients then receive human PSMA DNA vaccine IM once every 3 weeks for 3
doses (doses 4-6).
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity. Patients with stable or responding disease may receive additional booster
vaccinations with the second form of PSMA DNA vaccine received (for doses 4-6) every 8 weeks
for up to 4 additional doses.
Cohorts of 3-6 patients per arm receive escalating doses of human and mouse PSMA DNA vaccine
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Susan Slovin, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|