NCT00019916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 20, 2013

Status Verified

December 1, 2005

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Breast CancerOvarian Cancer

Keywords

stage IV breast cancerrecurrent breast cancerrecurrent ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

aldesleukinBIOLOGICAL
p53 peptide vaccineBIOLOGICAL
in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

NCI - Center for Cancer Research

Bethesda, Maryland, 20889, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

aldesleukinp53 synthetic long peptide vaccine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Samir N. Khleif, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

June 1, 2000

Study Completion

July 1, 2006

Last Updated

June 20, 2013

Record last verified: 2005-12

Locations

US(2)