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)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Biological: aldesleukin Biological: p53 peptide vaccine Procedure: in vitro-treated peripheral blood stem cell transplantation Phase 1 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
Study Start Date : June 2000
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks

Secondary Outcome Measures :
  1. Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
  2. Tumor response as measured by CT scan at baseline, and every 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019916

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20889
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Samir N. Khleif, MD National Cancer Institute (NCI) Identifier: NCT00019916     History of Changes
Obsolete Identifiers: NCT00001828
Other Study ID Numbers: CDR0000067279
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents