Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Lisata Therapeutics, Inc.
OBJECTIVES: * Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or recurrent melanoma. * Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen. * Determine the progression-free and overall survival in patients treated with this regimen. * Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen. OUTLINE: Patients are stratified according to presence of measurable disease at study initiation (yes vs no). Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion over approximately 4 months. The tumor cell line is expanded, irradiated, and treated with interferon gamma. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor cells for 18 hours. Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for an additional 5 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 4 years. PROJECTED ACCRUAL: A total of 30-80 patients will be accrued for this study.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
