Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
- 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
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment
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.
Allocation: Randomized, Primary Purpose: Treatment
Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
Samir N. Khleif, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|