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Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer, Ovarian Cancer

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Trial Information

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
these patients.

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.

Inclusion Criteria


- Histologically proven adenocarcinoma of the breast or ovary

- Stage IV, recurrent, or progressive disease with no chemotherapy or radiotherapy
options available that would increase survival

- Tumor tissue available for determination of p53 protein expression and genetic

- p53-positive tumor by immunohistochemical analysis

- HLA-A2.1 positive

- No prior CNS metastases

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0 or 1

Life expectancy:

- More than 3 months


- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2.0 mg/dL

- SGOT or SGPT no greater than 4 times normal

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative


- Creatinine no greater than 2.0 mg/dL


- No New York Heart Association class III or IV heart disease

- No myocardial infarction within past 6 months

- No prior congestive heart failure

- No prior ventricular arrhythmias or other arrhythmias requiring therapy


- Must have positive intradermal delayed hypersensitivity test for 1 of the following:

- Mumps

- Trichophyton

- Tetanus

- Candida


- No underlying immune deficiency

- No prior autoimmune disease including, but not limited to, the following:

- Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia

- Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma

- Myasthenia gravis

- Goodpasture's syndrome

- Addison's disease

- Hashimoto's thyroiditis

- Active Graves' disease

- No active infection requiring antibiotics

- HIV negative


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other active malignancy within the past 2 years except curatively treated
carcinoma in situ of the cervix or basal cell skin cancer


Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- At least 1 year since prior bone marrow transplantation


- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Prior anticancer hormonal therapy allowed

- At least 4 weeks since prior systemic steroids and recovered


- At least 4 weeks since prior radiotherapy and recovered


- Not specified


- Chronic suppressive antibiotics allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks

Safety Issue:


Principal Investigator

Samir N. Khleif, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

July 2006

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • recurrent ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Breast Neoplasms
  • Ovarian Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
NCI - Center for Cancer Research Bethesda, Maryland  20892