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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Metastatic Breast Cancer  Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic breast cancer.
Details: OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients. PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic adenocarcinoma of the breast; Tumor tissue positive for staining with DF3 (CA27-29) and/or DF3-P OR Elevated serum CA15-3 (CA27-29) - May have received no prior treatment or any number of prior regimens for metastatic disease - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Prior vaccinia virus exposure required; No other concurrent biologic therapy - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - Endocrine therapy: At least 3 weeks since prior hormonal therapy; No concurrent steroids or hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: No prior splenectomy - Other: At least 3 days since prior antibiotics --Patient Characteristics-- - Age: 18 and over - Menopausal status: Not specified - Performance status: ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: WBC greater than 2,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL; SGPT less than 4 times upper limit of normal - Renal: Creatinine less than 2.0 mg/dL - Immunologic: At least normal delayed type hypersensitivity; At least normal CD4:CD8 ratio (greater than 1); At least normal lymphocyte proliferation to concanavalin A; At least normal immunoglobulin levels; No evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); If no antivaccinia antibodies, then must have physician certification of prior vaccinia immunization OR patient recollection and appropriate vaccination site scar - Other: HIV negative; No prior or concurrent extensive skin disorders (e.g., eczema, extensive psoriasis, burns, impetigo, disseminated zoster); No other serious medical condition that would preclude study participation; No active infection requiring antibiotics; Must be able to avoid close contact with children under 3 years old, pregnant women, individuals with eczema or other skin conditions, and immunosuppressed people for 2 weeks after each vaccination; No seizures, encephalitis, or multiple sclerosis; No allergy to eggs; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldKufe, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000066886; DFCI-97050,NCI-T98-0057
Study Start Date: February 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003761
Other Stage 4 Breast Cancer Studies:
1. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
2. Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer
3. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
4. Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
5. Chemotherapy in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Massachusetts Clinical Trials
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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
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