Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Recruitment status was: Active, not recruiting
RATIONALE: Vaccines made from cancer cells may make the body build an immune response to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have acute lymphoblastic leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells|
|Study Start Date:||January 2001|
- 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 regimen.
- Determine, in a preliminary manner, the effect of this regimen on tumor response in these patients.
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 transplantation.
Patients are followed at approximately 2 months after last vaccination.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020670
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||W. Nicholas Haining, BM, BCh||Dana-Farber Cancer Institute|