Trial Outcomes & Findings for Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence (NCT NCT00030823)

Last Updated: 2015-12-30

Results Overview

By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

2 years

Results posted on

2015-12-30

Participant milestones
Measure	Vaccine Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Vaccine Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Overall Study Withdrawal by Subject	1

Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence

Baseline characteristics by cohort
Measure	Vaccine n=14 Participants Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

Timeframe: 2 years

Population: All 13 participants experienced toxicities.

By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.

Outcome measures
Measure	Vaccine n=13 Participants Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Safety	13 participants

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events
Measure	Vaccine n=13 participants at risk Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Blood and lymphatic system disorders SGPT (ALT)	7.7% 1/13 • Number of events 1

Other adverse events
Measure	Vaccine n=13 participants at risk Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
Musculoskeletal and connective tissue disorders Arthralgia (joint pain)	15.4% 2/13 • Number of events 4
Skin and subcutaneous tissue disorders Derm, skin other	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Dyspepsia/heartburn	7.7% 1/13 • Number of events 1
General disorders Fatigue	30.8% 4/13 • Number of events 7
General disorders Fever	7.7% 1/13 • Number of events 1
General disorders Headache	7.7% 1/13 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	7.7% 1/13 • Number of events 1
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • Number of events 1
Infections and infestations Injection site reaction	100.0% 13/13 • Number of events 39
Blood and lymphatic system disorders Leukocytes	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	7.7% 1/13 • Number of events 1
General disorders Pain, other	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Number of events 2
General disorders Rigors, chills	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders SGOT (AST)	7.7% 1/13 • Number of events 2
Blood and lymphatic system disorders SGPT (ALT)	7.7% 1/13 • Number of events 1

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4557