Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
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|ClinicalTrials.gov Identifier: NCT00030823|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 30, 2015
Last Update Posted : December 30, 2015
RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.
PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine Biological: QS21||Not Applicable|
- Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: 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.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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.
Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
- Safety [ Time Frame: 2 years ]By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030823
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Chair:||Teresa Ann Gilewski, MD||Memorial Sloan Kettering Cancer Center|