Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood

In brief

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.

Key facts

Study ID: NCT00923910
Run by: National Cancer Institute (NCI)
People needed: 10
Starts: 2008-02-22
Expected to finish: 2016-11-15
Last updated by the study team: 2017-04-12

Who can join

Age: 1 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Exclusion Criteria: Patient
Active graft versus host disease (GVHD) greater than grade 1 acute or extensive chronic.
Breast feeding or pregnant females (due to risk to fetus or newborn).
Central nervous system (CNS) malignancy by any of the following criteria:
Demonstration of malignant cells in the cerebrospinal fluid (CSF) in patients with leukemia or MDS as manifested by CSF white blood cell (WBC) greater than 5/microL and confirmation of CSF blasts.
Cranial neuropathies deemed secondary to the underlying malignancy.
CNS mass lesions deemed secondary to the underlying malignancy.
Neuroblastoma (NB): History of CNS involvement without current evidence of CNS malignancy is NOT an exclusion.
Rapidly progressive malignancy and/or clinically significant systemic illness (e.g., severe unstable infections or organ dysfunction) that in the judgment of the PI would likely compromise the patient's ability to tolerate this therapy or interfere with the study procedures, including but not limited to a life expectancy of less than 3 months.
High risk of inability to comply with protocol requirements as determined by principal investigator, social work, and primary team.
Human immunodeficiency virus (HIV) infection or human T-lymphotrophic virus type 1 (HTLV-1) infection (due to associated immune suppression and decreased likelihood of developing an immune response to the vaccine and increased risk of severe infection).
Active hepatitis B or C infection as defined by seropositive for hepatitis B surface antigen (HbSAg) or hepatitis C and elevated liver transaminases.
Corticosteroids (dexamethasone equivalent up to 0.1 mg/kg/day) will be permitted. Topical agents and/or inhaled corticosteroids are permitted.
Exclusion Criteria: Donor
History of medical illness that in the estimation of the principal investigator (PI) or Department of Transfusion Medicine (DTM)/NMDP physician poses prohibitive risk to donation.
Anemia (Hb less than 10 gm/dl) or thrombocytopenia (less than 100,000/microliter).
Breast feeding or pregnant females (due to risk to fetus or newborn).
High risk of inability to comply with protocol requirements as determined by the principal investigator and donor center team.
Positive screening test for transfusion-transmissible infection in accordance with DTM or NMDP donation standards.
Kaposi's sarcoma

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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