Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine whether endogenous cellular immunity to the p53 peptide vaccine is present in patients with stage IV, recurrent, or progressive breast or ovarian cancer and whether vaccination with these peptides and low-dose interleukin-2 can induce or boost the cellular immunity in these patients. * Determine the type and characteristics of cellular immunity generated by this regimen in these patients. * Determine the toxicity of this regimen in these patients. * Correlate any immunologic response with any objective tumor response to this regimen in these patients. OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms. All patients undergo apheresis of autologous peripheral blood mononuclear cells, which are harvested and selected for monocytes on day -6. The monocyte fraction is cultured with sargramostim (GM-CSF) and interleukin-4 for 7 days and then pulsed with p53 peptide vaccine. * Arm I: Patients receive p53 peptide vaccine subcutaneously (SC) on day 1. * Arm II: Patients receive p53 peptide vaccine IV over 5 minutes on day 1. Treatment in both arms repeats every 3 weeks for a total of 4 vaccinations (4 courses). During courses 3 and 4, patients also receive low-dose interleukin-2 (IL-2) SC daily on days 3-7 and days 10-14. Patients with stable or responding disease may continue to receive vaccine and IL-2 treatment for up to 2 years. Patients are followed at 1 month and then every 2-4 months for 2 years. PROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 2 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
