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

Primary Purpose

Breast Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
p53 peptide vaccine
in vitro-treated peripheral blood stem cell transplantation
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • NCI - Center for Cancer Research
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2001
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019916
Brief Title
Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer
Official Title
Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Cancer
Keywords
stage IV breast cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
p53 peptide vaccine
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
Secondary Outcome Measure Information:
Title
Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
Title
Tumor response as measured by CT scan at baseline, and every 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir N. Khleif, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCI - Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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