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

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.

Conditions

• Leukemia, Acute Myelogenous (AML)
• Leukemia, Acute Lymphocytic (ALL)
• Leukemia, Chronic Myelogenous (CML)
• Myelodysplastic Syndrome (MDS)
• Non-Hodgkin's Lymphoma (NHL)

Interventions

DRUG

WT1 Peptide-Pulsed Dendritic Cells

DRUG

Donor Lymphocytes

Lymphocytes from donors (related or unrelated) collected via lymphapheresis.

DRUG

IL-4

water-soluble protein; this study will use GMCSF (granulocyte macrophage colony stimulating factor)/IL-4 generated monocyte derived dendritic cells

DRUG

KLH

Neoantigen known to induce helper responses; will be used concurrently as a vaccine adjuvant and control antigen.

DRUG

WT1 Peptides

dendritic cell vaccine

DRUG

Endotoxin

Purified lipopolysaccharide prepared from E.Coli 0:113

DRUG

Diphenhydramine

Pre-medication

DRUG

Acetaminophen

Pre-medication

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Terry J Fry, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-22

Primary Completion

2013-10-18

Completion

2016-11-15

FDA Drug

Yes

Countries

• United States

Study Locations