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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Breast Cancer  Vaccine Therapy in Treating Patients With Breast Cancer
Vaccine Therapy in Treating Patients With Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer,stage 3B breast cancer,stage 4 breast cancer,recurrent breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have breast cancer.
Details: OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1. PROTOCOL OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosed breast cancer at high risk for disease recurrence with one of the following requirements: Disease free stage IV breast cancer following eradication of disease by surgery, radiotherapy, or chemotherapy; Stage I, II, or III breast cancer remaining clinically free of identifiable disease following adjuvant chemotherapy with 2 consecutively rising CA15.3 (BR2729) or CEA levels at least 2 weeks apart; Elevation of marker levels not needed for stage III disease if adjuvant therapy completed within past 2 years CEA increase at least 1.5 times upper chronic value in patients with significant smoking history and chronic CEA elevation less than 15; Recurrence in the ipsilateral axilla following lumpectomy/axillary dissection or modified radical mastectomy; Recurrence in the ipsilateral breast following lumpectomy/axillary dissection - Stage II disease with at least 4 positive axillary lymph nodes and adjuvant therapy completed within past 2 years; Stable stage IV disease on hormonal therapy - Colonoscopy required for isolated CEA elevation - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: At least 6 weeks since prior immunotherapy - 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 --Patient Characteristics-- - Age: 18 and over - Menopausal status: Not specified - Performance status: Karnofsky 90-100% - Life expectancy: Not specified - Hematopoietic: Lymphocyte count at least 500/mm3; WBC at least 3,000/mm3 - Hepatic: Alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 1.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No immunodeficiency or autoimmune disease; No seafood allergies; No other active malignancies except basal cell or squamous cell skin cancer; Not pregnant; Negative pregnancy test; Fertile patients must use effective barrier contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TeresaGilewski, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067394; MSKCC-99023,NCI-H99-0043
Study Start Date: May 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004156
Other Recurrent Breast Cancer Studies:
1. Vaccine Therapy in Treating Patients With Breast Cancer
2. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
3. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
4. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
5. Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
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Other recurrent breast cancer Clinical Trials
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Vaccine Therapy in Treating Patients With Breast Cancer
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