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NCT00923910 · ClinicalTrials.gov registry record · Phase 1
Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00923910: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923910 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923910, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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 1
Interventions
- DRUG KLH
- DRUG WT1 Peptide-Pulsed Dendritic Cells
- DRUG Donor Lymphocytes
- DRUG IL-4
- DRUG WT1 Peptides
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-02-22 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923910
The ClinicalTrials.gov registry entry for NCT00923910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which KLH is the first listed.
NCT00923910 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923910 about?
NCT00923910 is a clinical study titled "Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood". 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 in...
What is the current status of trial NCT00923910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2008-02-22. Estimated completion is 2016-11-15.
What interventions are being tested in trial NCT00923910?
The interventions under investigation include: KLH (DRUG), WT1 Peptide-Pulsed Dendritic Cells (DRUG), Donor Lymphocytes (DRUG), IL-4 (DRUG), WT1 Peptides (DRUG).
Who is sponsoring clinical trial NCT00923910?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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