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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.
Verified by Duke University, January 2010
First Received: May 4, 2008   Last Updated: January 13, 2010   History of Changes
Sponsor: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00672152
  Purpose

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.


Condition Intervention Phase
Acute Myelogenous Leukemia (AML)
Chronic Myelogenous Leukemia (CML)
Acute Lymphoblastic Leukemia (ALL)
Myelodysplastic Syndrome (MDS)
B Cell Malignancies
Biological: WT1 derived peptides
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: June 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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+.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672152

Locations
United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Liz Anderson, RN, BSN, OCN     919-684-6342     ander094@mc.duke.edu    
Principal Investigator: Michael A Morse, MD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Michael A Morse, MD Duke University
Study Director: Amy Hobeika, PhD Duke University
Principal Investigator: Nelson Chao, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University Medical Center ( Michael Morse, M.D. )
Study ID Numbers: BB-IND 13254
Study First Received: May 4, 2008
Last Updated: January 13, 2010
ClinicalTrials.gov Identifier: NCT00672152     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Autologous transplantation
Allogeneic transplantation

Additional relevant MeSH terms:
Leukemia, Lymphoid
Disease
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Precancerous Conditions
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Neoplasms
Preleukemia
Pathologic Processes
Syndrome
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 04, 2010