Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood
Status:
Completed
Trial end date:
2016-11-15
Target enrollment:
Participant gender:
Summary
Background:
- Most patients with acute lymphoblastic leukemia (ALL) and many patients with acute
myelogenous leukemia (AML), chronic myelogenous leukemia (CML) and non-Hodgkin's
lymphoma (NHL) have a protein called Wilm's Tumor 1 (WT1) in their cancer cells. This
protein is thought to be able to influence the growth of these cancers.
- A vaccine made with the WT1 protein may boost the immune system to help fight these
cancers in patients whose cancer cells contain the protein.
Objectives:
- To determine the safety, effectiveness and side effects of giving the WT1 vaccine and
donor white blood cells to patients with AML, ALL, CML or NHL who have previously
received standard treatment and undergone stem cell transplantation.
- To determine the immune response to the WT1 vaccine and donor white blood cells in these
patients and to determine if the response is related to the amount of WT1 protein in the
patient's cancer cells.
Eligibility:
- Patients between 1 and 75 years of age with the blood antigen human leukocyte antigen
(HLA-A2) and the WT1 cancer protein who have persistent or recurrent blood cancers after
stem cell transplantation.
- The prior stem cell transplant donor must be willing to provide additional cells, which
will be used to prepare the cellular vaccines and for donor lymphocyte (white blood
cell) infusions.
Design:
- Patients are given the WT1 vaccine every 2 weeks for 6 weeks (weeks 0, 2, 4, 6, 8, 10).
Each vaccination consists of two injections in the upper arm or thigh.
- On weeks 0, 4 and 8, patients also receive white blood cells from a donor to enhance the
immune response. The cells are also given as a 15- to 30-minute infusion through a vein
about 1 hour after the vaccine injection. Donor infusions are given only to patients
with mild or no graft-vs-host disease resulting from their prior stem cell
transplantation.
- Periodic physical examinations, blood and urine tests, scans to evaluate disease and
other tests as needed are done for 12 months after enrollment in the study.