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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence  Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
For Condition: Male Breast Cancer,Breast Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of breast cancer at high risk for recurrence, defined by one of the following: - Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy - May or may not have elevated CA 15-3 or CEA levels - Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels - Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart - For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart - Stage III and completed adjuvant therapy no more than 24 months ago - Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy - Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection - Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago - Stage IV that is stable on hormonal therapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Lymphocyte count at least 500/mm^3 - WBC at least 3,000/mm^3 Hepatic: - AST no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No clinically significant New York Heart Association class III or IV cardiac disease Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No prior seafood allergy - No known prior immunodeficiency or autoimmune disease - No other active cancer except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 weeks since prior immunotherapy - No prior vaccine with any of the antigens in this study Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery - Concurrent surgery for local recurrence allowed if patient remains disease free
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TeresaGilewski, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Teresa Gilewski 212-639-8319
Additional Information:
Study ID Numbers: CDR0000069200; NCI-H01-0084,MSKCC-01019
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030823
Other Male Breast Cancer Studies:
1. Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
2. Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
3. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
4. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
5. Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
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Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
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