Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments qs21, sialyl lewisª-keyhole limpet hemocyanin conjugate vaccine, immunoenzyme technique, immunologic technique, laboratory biomarker analysis
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date March 2007
End date March 2017
Trial size 7 participants
Trial identifier NCT00470574, 06-156, MSKCC-06156, P30CA008748

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
qs21
sialyl lewisª-keyhole limpet hemocyanin conjugate vaccine
immunoenzyme technique
immunologic technique
laboratory biomarker analysis

Primary Outcomes

Measure
Safety
time frame: 2 years
Immune response
time frame: 2 years

Secondary Outcomes

Measure
Presence of circulating tumor cells
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

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
Principal investigator Teresa Ann Gilewski, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.