Trials / Terminated

TerminatedNCT00672152

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

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
Phase: Phase 1
Study type: Interventional
Enrollment: 8 (actual)

Sponsor: Michael Morse, MD · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2007-06-01
Primary completion: 2013-04-01
Completion: 2013-10-01
First posted: 2008-05-06
Last updated: 2013-12-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00672152. Inclusion in this directory is not an endorsement.