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A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor

RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.

开始日期2004-11-01

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Wiseman Research Initiatives LLC

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2011-01-01·Mathematical Biosciences and Engineering4区 · 工程技术

Questions from the fourth son: A clinician reflects on immunomonitoring, surrogate markers and systems biology

4区 · 工程技术

ReviewOA

作者: Wiseman M D, Charles

The fourth son is the one who doesn't even know how to ask a question. Tumor immunology is challenged by the failure to identify reliable surrogate markers in vaccine and other experimental therapies for cancer; perhaps investigators haven't yet asked the right questions. Unlike prophylactic vaccines for infectious disease, where the development of antibody is considered a satisfactory endpoint, no such endpoint exists for human therapeutic vaccines. Why is this? Despite an extensive roster of in vitro assays that correlate immune responses to favorable clinical outcomes, no assay is sufficiently reliable to be usefully predictive for vaccine therapy. The discussion reviews some of the historical developments in tumor immunology and the problem of defining a causal relationship when strong correlations are identified. The development of mathematical models from empirical data may help inform the clinician/scientist about underlying mechanisms and help frame new testable hypotheses.

2010-02-01·The Open Breast Cancer Journal

Phase I Study with SV-BR-1 Breast Cancer Cell Line Vaccine and GMCSF: Clinical Experience in 14 Patients

作者: Wiseman, Charles L. ; Kharazi, Alex

We evaluated the safety and feasibility of breast cancer vaccine therapy using a new cell line, SV-BR-1, in conjunction with repeated injections of GM-CSF, as a prototype for a subsequent genetically engineered vaccine.Also addressed with this preliminary trial were monitoring effects on quality of life, screening for potential immune responses, and evaluating any clin. effects on tumor progression and patient survival.Fourteen patients with metastatic breast cancer were treated with SV-BR-1 tumor cells.The cell line strongly overexpresses HER2/neu, and has an unusual variety of cytogenetic abnormalities.Irradiated whole-cell suspensions (median dose 14 × 10⁶ viable cells) were inoculated via intradermal injection or intralymphatic cannulation, the former usually including an equal amount of irradiated autologous peripheral blood lymphocytes (PBL).Vaccine was initially given at 2-wk intervals x3, then monthly.Low-dose cyclophosphamide 300mg/m² was given 48-72 h prior to vaccine, and GM-CSF (125 mcg) was given s.c. immediately prior and for 8 days subsequently.The Kaplan-Meier mean survival for all 14 patients was 17.2 mo (CI 5.8-28.5 mo) and was 21.1 mo (95% CI 5.0-37.2 mo) for nine patients treated with the tumor cell/PBL admixture, although there were no clin. regressions.SV-BR-1 as a whole-cell vaccine appears feasible and without obvious major toxicity.The overall survival compares favorably with current Phase I studies.Based on these observations, we have initiated a clin. trial using the SV-BR-1 cell line transfected to release GM-CSF in situ with four patients to date.One case responded with clear evidence of tumor regressions in multiple sites and the median survival of 35.0 mo is three times longer than usual expectations for salvage programs.

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