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

NCT00672152 | Terminated Phase 1

• 1 other identifier: Pro00001360
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autologous transplantation; Allogeneic transplantation

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility

  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.

  2 years

Secondary Outcomes (2)

• Immune Response

  2 years

• Efficacy (PFS and OS)

  2 years

Study Arms (1)

A-WT1 derived peptides

EXPERIMENTAL

Wilms' tumor gene 1 (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 Granulocyte-macrophage colony-stimulating factor (GM-CSF) in a total volume of 2ml: * WT peptide #1: (human leukocyte antigen) 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.

Biological: WT1 derived peptides

Interventions

WT1 derived peptides BIOLOGICAL

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-WT1 derived peptides

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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+.

Sponsors & Collaborators

• Michael Morse, MD: lead

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael A Morse, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Amy Hobeika, PhD

  Duke University

  STUDY DIRECTOR

• Nelson Chao, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: May 6, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)