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


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Teresa Ann Gilewski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-156

NCT ID:

NCT00470574

Start Date:

March 2007

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021