Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System
To become eligible for therapy the following criteria must be fulfilled:
- No age or gender limit
- Patients with atypical malignant brain tumors.
- Must have a Karnofsky performance of at least 60%
- Hematologic studies and chemistry profiles will be within the parameters of the
- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide
must be generated in sufficient quantity and patient must have no prior sensitivity to
the components of the dendritic cell vaccine.
- Patients are excluded if they have systemic disease, presence of acute infection, known
history of autoimmune disorder and pregnancy.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
John Yu, M.D.
Cedars-Sinai Medical Center
United States: Food and Drug Administration
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|