Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission

January 3, 2014 updated by: The Vaccine Company

A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CSF.

Secondary

  • Compare improvement of relapse-free survival of patients treated with these regimens.
  • Compare remission duration in patients treated with these regimens.
  • Compare immune response, as measured by PR1-HLA-A2 tetramer assay, in patients treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to age and complete remission (CR) (≥ 18 years of age and in second CR vs ≥ 55 years of age and in first CR), type of acute myeloid leukemia (de novo vs secondary), and cytogenetics (unfavorable vs favorable and intermediate). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously (SC).
  • Arm II: Patients receive placebo vaccine and GM-CSF SC.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • South San Francisco, California, United States, 94080
        • Vaccine Company
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute at Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Hospital Cancer Care Services
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Centers
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • San Antonio, Texas, United States, 78222
        • Cancer Care Centers of South Texas - Southeast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML), defined by the presence of > 20% blasts in marrow or blood, including the following subtypes:

    • De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents

    • Secondary AML, defined as the following:

      • AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure
      • History of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia

  • In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 18 years of age) within the past month

    • FAB stages M0-M2 and M4-M7 allowed if in first CR

      • No acute promyelocytic leukemia in first CR
    • FAB stages M0-M7 allowed if in second CR

    • Marrow blast count < 5% (≤ 200 nucleated cell count)

      • No blasts in blood
  • HLA-A2 positive at 1 allele
  • No extramedullary disease
  • No Auer rods
  • No active meningeal or CNS leukemia

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy must not be severely limited by other diseases
  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3
  • Bilirubin < 2 mg/mL
  • ALT < 2 times upper limit of normal
  • Creatinine ≤ 1.6 mg/mL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Antineutrophil cytoplasmic antibody negative
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient
  • No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast
  • No known allergy to incomplete Freund's adjuvant
  • No hypercalcemia

  • No progressive viral or bacterial infection

    • Must be afebrile for 7 days without antibiotics
  • No symptomatic cardiac disease
  • LVEF ≥ 40%
  • No symptomatic pulmonary disease
  • FEV_1, FVC, and DLCO ≥ 50% of predicated (without bronchodilator)
  • No history of HIV positivity or AIDS
  • No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product
  • No history of Wegener's granulomatosis or vasculitis

PRIOR CONCURRENT THERAPY:

  • Recovered from prior surgery and/or radiotherapy
  • No prior allogeneic or syngeneic stem cell transplantation
  • No prior solid organ transplantation
  • No prior vaccine therapy for AML

  • More than 28 days since prior chronic use (> 2 weeks) of corticosteroids > 10 mg/day (prednisone [or equivalent])

    • Concurrent topical or inhaled corticosteroids allowed
  • More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus
  • No concurrent radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.
Biological: sargramostim
Given subcutaneously
Biological: PR1 leukemia peptide vaccine
Given subcutaneously
Active Comparator: Arm II
Patients receive placebo vaccine and GM-CSF subcutaneously.
Biological: sargramostim
Given subcutaneously
Other: placebo
Given subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Relapse-free survival
Remission duration
Immune response as measured by PR1-HLA-A2 tetramer assay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Vaccine Company

Investigators

  • Study Chair: Craig S. Rosenfeld, MD, The Vaccine Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 30, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000510853
  • VACCINE-PR1-104
  • UCCRC-14613B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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