Finding studies
Finding studies
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Lead
University of Pennsylvania
With
Description of treatment for Phase I: * Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine. * If subjects have not received DCVax-L vaccination within the last 3-4 weeks, and if DCVax-L is available, subjects have the option of receiving one dose of DCVax-L after enrolment, to boost the frequency of vaccine-primed T cells. * Subjects will receive a single course of outpatient lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 days) and intravenous fludarabine (30 mg/m2/d for 3 days) both administered on days 8 to 10. * Ex vivo CD3/CD28-costimulated lymphocytes will be infused \~2 days after last day of fludarabine infusion. * Patients will receive DCVax-L vaccine \~24-48 hrs after T cell infusion. * Subjects will be contacted every 6 months for 5 years for survival. Description of treatment for Phase II: In ARM-IIA: * Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine. * Subjects will receive intradermal vaccinations with DCVax-L every 8 weeks, for four cycles total. The first vaccine will be administered on day 0, which can be no sooner than 4 weeks from previous DCVax-L vaccination related to clinical study UPCC-11807. * Subjects will receive oral cyclophosphamide at metronomic schedule and dose (50 mg daily) every other week, starting \~3 weeks after DCVax-L in every vaccine cycle. * Patients will be offered (with the right to refuse) CT-guided needle biopsy or needle aspiration of malignant effusion after the second vaccine. In ARM-IIB: * Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine. * Subjects will undergo \~10-15 liter leukapheresis to derive vaccine-primed peripheral blood lymphocytes (PBL) on day 0. The apheresis material will be transferred to the Cell and Vaccine Facility at the University of Pennsylvania (Penn CVPF) for T cell manufacturing. * If subjects have not received DCVax-L vaccination within the last 3-4 weeks, and if DCVax-L is available, subjects have the option of receiving one dose of DCVax-L after enrolment, to boost the frequency of vaccine-primed T cells. * Subjects will receive a single course of outpatient lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 days) and intravenous fludarabine (30 mg/m2/d for 3 days). * Ex vivo CD3/CD28-costimulated lymphocytes will be infused \~2 days after last day of fludarabine infusion. * Patients will receive DCVax-L vaccine boosts every 8 weeks for a total of four vaccines. The first DCVax-L will be given \~24-48 hrs after T cell infusion. * Following DCVax-L, subjects will receive oral cyclophosphamide at metronomic schedule and dose (50 mg daily) every other week x 3 cycles, starting \~3 weeks after DCVax-L in every vaccine cycle. * Patients will be offered (with the right to refuse) CT-guided needle biopsy or needle aspiration of malignant effusion \~1-2 weeks after the second vaccine
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
