Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

November 16, 2020 updated by: Memorial Sloan Kettering Cancer Center

Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 2 years
2 years
Immune Response
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of Circulating Tumor Cells
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Teresa Ann Gilewski, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2007

Primary Completion (Actual)

January 24, 2020

Study Completion (Actual)

January 24, 2020

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 7, 2007

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-156
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-06156

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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