Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00470574
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 154.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Biological: QS21; Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Mar 20, 2007
• Actual Primary Completion Date: Jan 24, 2020
• Actual Study Completion Date: Jan 24, 2020

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. Safety [2 years]

2. Immune Response [2 years]

Secondary Outcome Measures

1. Presence of Circulating Tumor Cells [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Teresa Ann Gilewski, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 24, 2018

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00470574
• Other Study ID Numbers: 06-156; P30CA008748; MSKCC-06156
• First Posted: May 7, 2007
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Memorial Sloan Kettering Cancer Center: recurrent breast cancer; stage IV breast cancer; male breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Keyhole-limpet hemocyanin

Study Results

Participant Flow

Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
Overall Participants	7
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	44
Sex: Female, Male (Count of Participants)
Female	7 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 14.3%
Not Hispanic or Latino	6 85.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 14.3%
White	6 85.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Safety
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
Measure Participants	0

2. Primary Outcome

Title	Immune Response
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
Measure Participants	0

3. Secondary Outcome

Title	Presence of Circulating Tumor Cells
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
Measure Participants	0

Adverse Events

Time Frame	2 years
Arm/Group Title	Vaccine Therapy and QS21
Arm/Group Description	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
All Cause Mortality
	Vaccine Therapy and QS21
	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)
Serious Adverse Events
	Vaccine Therapy and QS21
	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)
Eye disorders
Ocular/Visual - Other (specify)	1/7 (14.3%)
Metabolism and nutrition disorders
Potassium, low (hypokalemia)	1/7 (14.3%)
Skin and subcutaneous tissue disorders
Rash/desquamation	1/7 (14.3%)
Other (Not Including Serious) Adverse Events
	Vaccine Therapy and QS21
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Blood and lymphatic system disorders
Hemoglobin	1/7 (14.3%)
Leukocytes (total WBC)	1/7 (14.3%)
Eye disorders
Ocular/Visual - Other (specify)	1/7 (14.3%)
Gastrointestinal disorders
Nausea	3/7 (42.9%)
Diarrhea	2/7 (28.6%)
Constipation	1/7 (14.3%)
Mucositis (func/sympt)- Oral cavity	1/7 (14.3%)
Vomiting	1/7 (14.3%)
General disorders
Injection site reaction/extravasation	7/7 (100%)
Fatigue (asthenia, lethargy, malaise)	4/7 (57.1%)
Edema: limb	1/7 (14.3%)
Fever (in the absence of neutropenia)	1/7 (14.3%)
Rigors/chills	1/7 (14.3%)
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)	3/7 (42.9%)
Glucose, high (hyperglycemia)	3/7 (42.9%)
Metabolic/Lab - Other (specify)	3/7 (42.9%)
Sodium, high (hypernatremia)	1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Pain - Muscle	3/7 (42.9%)
Pain - Joint	2/7 (28.6%)
Nervous system disorders
Pain - Head/headache	3/7 (42.9%)
Respiratory, thoracic and mediastinal disorders
Cough	1/7 (14.3%)
Skin and subcutaneous tissue disorders
Dermatology/Skin, other	3/7 (42.9%)
Hair loss/alopecia (scalp or body)	1/7 (14.3%)
Pruritus/itching	1/7 (14.3%)
Rash/desquamation	1/7 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.