A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation — WT-1  

Myelodysplastic Syndrome (MDS) Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Two subgroups with 2 dose cohorts of up to 6 patients each will be enrolled in this exploratory study in order to attempt to obtain immunologic and clinical data on patients with a variety of hematologic malignancies and amongst those in remission and early relapse. The 2 subgroups of patients will be treated with different schemas depending upon whether they are undergoing or have undergone autologous or allogeneic stem cell transplantation.

For the autologous transplant patients: Immune monitoring will require 90ml peripheral blood before the first immunization, 3-5 ml from the leukapheresis product, 40-90ml peripheral blood before the 4th immunization immunizations, after the last immunization (week 6-8), and at the discretion of the immune monitoring lab, every two months if immunizations are continued.

For the allogeneic transplant patients: Immune monitoring will require 90ml peripheral blood before the first immunization, 40-90ml peripheral blood before the 4th immunization immunizations, after the last immunization (week 6-8), and at the discretion of the immune monitoring lab, every two months if immunizations are continued.

Subjects will be monitored with blood pressure, temperature, and pulse, pre-injection, at 15 and 30 minutes after injection, prior to being allowed to leave the clinic. Diphenhydramine 50 mg, solumedrol 100 mg, and epinephrine 1:1000 (1 mL) must be available bedside (or a clinic code cart must be available). If hypotension (SBP <90mmHg for patients with baseline SBP > 110mmHg or > 20 mmHg decrease for those with baseline SBP< 110 mmHg), urticaria or orofacial or laryngeal edema or bronchospasm occurs, an IV line will be placed and the diphenhydramine 50 mg, solumedrol 100 mg, and epinephrine 1:1000 sq are recommended. In this event, patients will be transported emergently to the emergency room if stabilized or the code team will be contacted if patients continue to have progression of symptoms or worsening hypotension. For fever>101.5, acetaminophen 650 mg may be given orally. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Acute Myelogenous Leukemia (AML)
• B Cell Malignancies
• Chronic Myelogenous Leukemia (CML)
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

• NCT number: NCT00672152
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: Phase 1
• Start date: June 2007
• Completion date: October 2013