|
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence Clinical research trials and Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence. Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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 Breast Cancer Studies:
1. Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
2. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
3. Decitabine in Treating Patients With Advanced Solid Tumors
4. Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
5. Chemotherapy in Treating Patients With Breast Cancer
Related Studies:
Other Breast Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
|
|
|
|
|
|
|
|
