Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470574
• Other study ID #: 06-156
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: N/A
• Start date: March 20, 2007
• Est. completion date: January 24, 2020

Study information

• Verified date: November 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• QS21

• sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine

Other:
• immunoenzyme technique

• immunologic technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		2 years
Primary	Immune Response		2 years
Secondary	Presence of Circulating Tumor Cells		2 years

External Links

•   Memorial Sloan Kettering Cancer Center