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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.

Interventions

  • DRUG KLH
  • DRUG WT1 Peptide-Pulsed Dendritic Cells
  • DRUG Donor Lymphocytes
  • DRUG IL-4
  • DRUG WT1 Peptides

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2008-02-22
Est. Completion 2016-11-15
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00923910 record still lists

NCT00923910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 5 interventions - of which KLH is the first listed.

NCT00923910 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00923910's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00923910, the US trial registry maintained by the National Library of Medicine. NCT00923910 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.