Trial Outcomes & Findings for Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer (NCT NCT00470574)
NCT ID: NCT00470574
Last Updated: 2020-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
2 years
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Vaccine Therapy and QS21
n=7 Participants
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
|
|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Vaccine Therapy and QS21
Serious events: 3 serious events
Other events: 7 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Vaccine Therapy and QS21
n=7 participants at risk
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
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|---|---|
|
Eye disorders
Ocular/Visual - Other (specify)
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
1/7 • 2 years
|
Other adverse events
| Measure |
Vaccine Therapy and QS21
n=7 participants at risk
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
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|---|---|
|
General disorders
Injection site reaction/extravasation
|
100.0%
7/7 • 2 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
57.1%
4/7 • 2 years
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
42.9%
3/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
42.9%
3/7 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
42.9%
3/7 • 2 years
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other (specify)
|
42.9%
3/7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
42.9%
3/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
42.9%
3/7 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
28.6%
2/7 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 2 years
|
|
General disorders
Edema: limb
|
14.3%
1/7 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
14.3%
1/7 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.3%
1/7 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Mucositis (func/sympt)- Oral cavity
|
14.3%
1/7 • 2 years
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
1/7 • 2 years
|
|
General disorders
Rigors/chills
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 2 years
|
Additional Information
Teresa Gilewski, MD
Memorial Sloan Kettering Cancer Center
Phone: (212) 639-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place