Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019916
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
June 20, 2013
June 2000
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Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
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Complete list of historical versions of study NCT00019916 on Archive Site
  • Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
  • Tumor response as measured by CT scan at baseline, and every 3 months
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Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer
Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet known whether combining vaccine therapy with interleukin-2 is effective in treating breast and ovarian cancer.

PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and interleukin-2 and to see how well they work in treating women with stage IV, recurrent, or progressive breast or ovarian cancer.


  • 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.

Phase 1
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Breast Cancer
  • Ovarian Cancer
  • Biological: aldesleukin
  • Biological: p53 peptide vaccine
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2006
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  • 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 mutation

    • 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
    • PPD
  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Cancer Institute (NCI)
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Principal Investigator: Samir N. Khleif, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP