A Pilot Study of Tumor Lysate-pulsed Dendritic Cell Vaccine for Immune Augmentation for High-risk Solid Tumor Patients Following Autologous Stem Cell Transplantation
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be
effectively treated with a combination of surgery, radiation and chemotherapy. However,
patients with metastatic or relapsed disease have a very poor prognosis.
For the past decade, efforts to increase overall survival and progression-free survival for
patients with high-risk pediatric and young adult tumors, have evaluated the use of
high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT). The proportion of
patients who enter a complete remission with HSCT is high, ranging from 81 to 90%. While
autologous HSCT renders a large proportion of patients temporarily disease-free, relapse
develops in the majority of patients.
Survival appears to have been most improved with this strategy for neuroblastoma, but
relapses occur in the majority of patients. Similar strategies have also been tried for
patients with advanced stage sarcoma and Wilms' tumor, but relapses are even more
New approaches to the management of these difficult groups of patients are needed. There is
evidence to suggest that solid tumors may be good candidates for immunotherapy approaches.
In fact, recent experimental evidence indicates that the period of lymphopenia that occurs
after HSCT may be an opportune time to use this treatment approach. In light of the very
poor prognosis of young patients with advanced solid tumors, this treatment approach
warrants further investigation.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the rate of immune response of this immunotherapy treatment
James D Geiger, M.D.
University of Michigan, Department of Surgery, Pediatric Section
United States: Food and Drug Administration
|University of Michigan, Department of Surgery, Pediatric Section||Ann Arbor, Michigan 48170|