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A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CML, ALL, MDS, and B Cell Malignancies (WT-1)
This study is currently recruiting participants.
Study NCT00672152   Information provided by Duke University
First Received: May 4, 2008   Last Updated: January 13, 2010   History of Changes

May 4, 2008
January 13, 2010
June 2007
June 2010   (final data collection date for primary outcome measure)
To determine the safety and feasibility of administering WT1 peptides to subjects who have undergone autologous or allogeneic stem cell transplantation for AML, CML, ALL, B cell malignancies and myelodysplastic syndrome. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672152 on ClinicalTrials.gov Archive Site
  • To evaluate the immune response to immunizations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Investigate clinical activity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
 
A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CML, ALL, MDS, and B Cell Malignancies
A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CmML, ALL, MDS, and B Cell Malignancies

The purpose of this study is to determine the safety and effectiveness of administering 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 GM-CSF which may help make the immune response stronger.

 
Phase I
Interventional
Control:  Dose Comparison
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment
  • Acute Myelogenous Leukemia (AML)
  • Chronic Myelogenous Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Myelodysplastic Syndrome (MDS)
  • B Cell Malignancies
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.

A: Experimental
Intervention: Biological: WT1 derived peptides
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
15
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

There are two subgroups of patients: Those undergoing autologous stem cell transplantation and those undergoing allogeneic stem cell transplantation.

Autologous transplant subgroup:

-Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who will be undergoing autologous stem cell transplantation.

Allogeneic transplantation subgroup:

-Patients with the following hematologic malignancies (AML, CML, ALL, B cell malignancies, and myelodysplastic syndrome) who have undergone allogeneic stem cell transplantation. There is no limitation on whether myeloablative or non-myeloablative chemotherapy is administered. A 3/6 or greater match is required for patients who have had an allogeneic stem cell transplant.

Both subgroups:

  • Subject must be one of the following HLA types: HLA A2, A24, DR15 or DRw53 (includes HLA-DR4, -DR7, and DRw9)
  • Karnofsky performance status must be greater than or equal to 70%.
  • Age ≥ 18 years.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
  • Patient must agree to use adequate contraception defined as: for women, one of the following (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); for men, one of the following: (1) surgical sterilization, or (2) a condom used with a spermicide.
  • In order to receive their immunizations, subjects should be:

For autologous transplants:

  • At least 2 weeks from prior chemotherapy.
  • Injections 1 and 2 must be completed prior to administration of any growth factor mobilization
  • Injections 3, 4, 5, and 6, to resume 2 or more weeks from the time of their stem cell infusion if there has been no Grade 3 or 4 non-hematologic, major organ toxicity within the preceding 1 week. Non-major organ toxicities must have resolved to grade 2 or less.

For allogeneic transplants,

  • At least 2 weeks from the time of their stem cell infusion.
  • Without Grade 3 or 4 non-hematologic major organ toxicity within the preceding 1 week; non major organ toxicities must have resolved to grade 2 or less.
  • We will require demonstration of >50% donor myeloid hematopoiesis, based on microsatellite polymorphisms, prior to enrolling the patients with MDS on the study.

    • Adequate laboratory data as follows:

Hematologic function: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (may transfuse or use erythropoietin to achieve this level), platelets ≥ 50,000/microliter ((may transfuse).

Renal and hepatic function: serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except a bilirubin of <2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT < 2 x upper limit of normal.

  • Subjects must have a CD4+ count is > 200/mm. There is no specified requirement for CD8+ T cell count.
  • Urine protein/creatinine ratio (UPC) must be less than 1.

Exclusion Criteria:

  • Corticosteroid (greater than 10mg per day of prednisone or an equipotent dose of another corticosteroid) or other immunosuppressive therapy within the prior 1 week.
  • Pregnant women and nursing mothers.
  • Current or prior history of brain metastases.
  • More than 12 months since their stem cell transplant.
  • HIV +, hepatitis BsAg +, Hepatitis C Ab+.
Both
18 Years and older
No
 
United States
 
NCT00672152
Michael Morse, M.D., Duke University Medical Center
BB-IND 13254
Duke University
 
Principal Investigator: Michael A Morse, MD Duke University
Study Director: Amy Hobeika, PhD Duke University
Principal Investigator: Nelson Chao, MD Duke University
Duke University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP