Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00470574
First received: May 3, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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
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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Immune response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of circulating tumor cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: March 2007
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470574

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Teresa Ann Gilewski, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Maura N. Dickler, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00470574     History of Changes
Other Study ID Numbers: 06-156, P30CA008748, MSKCC-06156
Study First Received: May 3, 2007
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Keyhole-limpet hemocyanin
QS 21
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014