A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
- Determine the feasibility of generating a vaccine comprising CD40-activated autologous
leukemic cells for patients with B-cell acute lymphoblastic leukemia (ALL).
- Determine the feasibility of this regimen in patients with B-cell ALL.
- Determine the toxicity of this regimen in these patients.
- Assess the ALL-specific immunity in patients treated with this regimen.
- Assess the generation of immunity to control antigens in patients treated with this
- Determine, in a preliminary manner, the effect of this regimen on tumor response in
OUTLINE: This is a multicenter study.
Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40
ligand, pulsed with keyhole limpet hemocyanin, and then irradiated.
Beginning a minimum of 1 week after tumor cell collection, patients receive vaccination with
autologous CD40-activated ALL cells subcutaneously and intradermally on weeks 0, 2, 4, and 6
in the absence of disease progression or unacceptable toxicity. After completion of 4
vaccinations, patients who have more aliquots of vaccine available from the initial tumor
cell collection may receive additional vaccinations every 2 weeks in the absence of disease
progression or unacceptable toxicity. Vaccination may be postponed for a maximum of 1 year
after tumor cell collection in patients who receive chemotherapy and/or allogeneic stem cell
Patients are followed at approximately 2 months after last vaccination.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
W. Nicholas Haining, BM, BCh
Dana-Farber Cancer Institute
United States: Federal Government
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|