- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019916
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.
Study Overview
Status
Conditions
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, United States, 20889
- NCI - Center for Cancer Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samir N. Khleif, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Breast Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Aldesleukin
Other Study ID Numbers
- CDR0000067279
- NCI-99-C-0138
- NCI-NMOB-9902
- NCI-T99-0075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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