Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
18 Years
N/A
Female
Breast Cancer, Ovarian Cancer
Trial Information
Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0 or 1
Life expectancy:
- More than 3 months
Hematopoietic:
- Platelet count at least 100,000/mm^3
Hepatic:
- 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
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- 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
Immunologic:
- 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
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- At least 1 year since prior bone marrow transplantation
Chemotherapy:
- 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
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- Chronic suppressive antibiotics allowed
Type of Study:
Interventional
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:
No
Principal Investigator
Samir N. Khleif, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000067279
NCT ID:
NCT00019916
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
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
| NCI - Center for Cancer Research | Bethesda, Maryland 20892 |
