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
Jonsson Comprehensive Cancer Center
OBJECTIVES: Primary * Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma. * Determine the maximum tolerated dose of this vaccine in these patients. Secondary * Determine, preliminarily, the survival of patients treated with this vaccine. * Determine, preliminarily, the time to tumor progression in patients treated with this vaccine. * Determine cellular immune response in patients treated with this vaccine. * Determine age-dependent differences in response to this vaccine, in terms of immunocompetence, in these patients. OUTLINE: This is a dose-escalation study. Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed at 2 weeks and then every 2 months for 1 year. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5 years.
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
