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Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00470574
Enrollment
7
Registered
2007-05-07
Start date
2007-03-20
Completion date
2020-01-24
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

recurrent breast cancer, stage IV breast cancer, male breast cancer

Brief 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.

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.

Interventions

BIOLOGICALQS21
BIOLOGICALsialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine
OTHERimmunoenzyme technique
OTHERimmunologic technique
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety2 years
Immune Response2 years

Secondary

MeasureTime frame
Presence of Circulating Tumor Cells2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
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
7
Total7

Baseline characteristics

CharacteristicVaccine Therapy and QS21
Age, Continuous44 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
7 Participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
4 / 7
other
Total, other adverse events
7 / 7
serious
Total, serious adverse events
3 / 7

Outcome results

Primary

Immune Response

Time frame: 2 years

Population: Data were not collected

Primary

Safety

Time frame: 2 years

Population: Data were not collected

Secondary

Presence of Circulating Tumor Cells

Time frame: 2 years

Population: Data were not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026