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A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation

NCT00672152 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-12-10

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and effectiveness of administering Wilms tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made in a laboratory to be like the peptides that can be found in cancer. These peptides are intended to be given as a "vaccine" to activate the immune cells in a person to attack his/her cancer. These peptides are mixed with an oily substance called Montanide ISA-51 and a white cell growth factor called Granulocyte-macrophage colony-stimulating factor (GM-CSF) which may help make the immune response stronger.

Conditions

  • Acute Myelogenous Leukemia (AML)
  • Chronic Myelogenous Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Myelodysplastic Syndrome (MDS)
  • B Cell Malignancies

Interventions

BIOLOGICAL

WT1 derived peptides

WT1 derived peptides consisting of 0.3mg (cohort 1) or 1mg (cohort 2) of each of the following peptides mixed with 1ml Montanide ISA 51 and 100mcg GM-CSF in a total volume of 2ml: * WT peptide #1: HLA-A2 restricted: RMFPNAPYL * WT peptide #2: HLA-A24 restricted: CMTWNQMNL * WT peptide #3: HLA-DR15 restricted: QARMFPNAPYLPSCL * WT peptide #4: HLA-DRw53 restricted: LKGVAAGSSSSVKWT Immunization with the peptide pools will be given as 200 microliter intradermal and 1.8ml subcutaneously in opposite thighs.

Sponsors & Collaborators

  • Michael Morse, MD

    lead OTHER

Principal Investigators

  • Michael A Morse, MD · Duke University

  • Amy Hobeika, PhD · Duke University

  • Nelson Chao, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672152 on ClinicalTrials.gov