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Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00470574
Recruitment Status : Completed
First Posted : May 7, 2007
Results First Posted : November 16, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Biological: QS21 Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis Not Applicable

Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
  • Determine the IgG and IgM antibody response to this regimen in these patients.
  • Determine the proportion of breast cancer cells expressing this antigen in these patients.

Secondary

  • Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : March 20, 2007
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : January 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccine Therapy and QS21

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

 Biological: QS21
Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine
Other: immunoenzyme technique
Other: immunologic technique
Other: laboratory biomarker analysis


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 2 years ]
  2. Immune Response [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Presence of Circulating Tumor Cells [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:

    • No evidence of disease

    • Stable disease on hormonal therapy

      • Stable disease must be present for ≥ 2 months and include < 30% decrease or < 20% increase in the sum of the longest diameter of target lesion
      • No new target lesions or unequivocal progression of non-target lesions
      • Elevation in the CA 153 (BR2729) or CEA values allowed
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female or male
  • Menopausal status not specified
  • Karnofsky performance status 80-100%
  • Lymphocyte count ≥ 500/mm³
  • WBC ≥ 3,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergy to seafood
  • No NYHA class III-IV cardiac disease
  • No other active cancers except basal cell or squamous cell carcinoma of the skin
  • No active infection requiring antibiotic treatment
  • No known history of immunodeficiency or autoimmune disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery
  • At least 6 weeks since prior immunotherapy
  • No prior sialyl Lewisª antigen
  • No concurrent immunosuppressive medications (i.e., corticosteroids)
  • Concurrent hormonal therapy allowed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470574


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Teresa Ann Gilewski, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2018

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00470574    
Other Study ID Numbers: 06-156
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-06156
First Posted: May 7, 2007    Key Record Dates
Results First Posted: November 16, 2020
Last Update Posted: November 18, 2020
Last Verified: November 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent breast cancer
stage IV breast cancer
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs