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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470574 |
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Condition | Intervention |
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Breast Cancer |
Biological: QS21 Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21 |
Estimated Enrollment: | 23 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
Stable disease on hormonal therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Teresa Ann Gilewski, MD 646-888-4557 |
Principal Investigator: | Teresa Ann Gilewski, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Maura N. Dickler, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000542903, MSKCC-06156 |
Study First Received: | May 3, 2007 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00470574 History of Changes |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer male breast cancer |
Immunologic Factors Skin Diseases Breast Neoplasms, Male Adjuvants, Immunologic Breast Neoplasms |
Breast Cancer, Male QS 21 Keyhole-limpet hemocyanin Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Immunologic Factors Skin Diseases Physiological Effects of Drugs Adjuvants, Immunologic |
Breast Neoplasms QS 21 Keyhole-limpet hemocyanin Pharmacologic Actions Breast Diseases |