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Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01266083
First received: December 21, 2010
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether the WT1 vaccine causes an immune response which is safe and able to keep the leukemia from coming back. While vaccines have been used in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of protein pieces that the immune system can recognize as abnormal. The doctor thinks that the WT-1 protein is important in AML/ALL and using some lab tests they are still able to find some of it in the bone marrow. By attacking this small amount of the protein they hope to get rid of any small amount of AML that is still in the body.


Condition Intervention Phase
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biological: WT1 peptide vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of a WT-1 Analog Peptide Vaccine in Patients in Complete Remission (CR) From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To assess the safety [ Time Frame: at weeks 2 and 4 with routine toxicity assessments throughout the trial ] [ Designated as safety issue: Yes ]
    of the WT1 peptide vaccine administered to patients in CR from AML. Early toxicity will be assessed at weeks 2 and 4,. Routine toxicity assessments will continue throughout the trial. Any toxicity noted in the trial will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) developed by the National Cancer Institute.

  • To assess the efficacy of the WT1 peptide vaccine administered to patients in CR from AML. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The primary efficacy measure is defined as overall survival at 3 years.


Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the immunologic responses of vaccine administration [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    via CD4+ T cell proliferation, CD3+ T cell interferon- γ release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining.

  • To assess any effect on minimal residual disease [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    as measured by RT-PCR for WT1 transcript.


Estimated Enrollment: 29
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WT1 peptide vaccine
This is a Phase II study evaluating the safety and efficacy of the WT1 peptide vaccine in patients who are in CR from Acute Myeloid Leukemia (AML).
Biological: WT1 peptide vaccine
Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, and 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Patients who are clinically stable and have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month.

  Eligibility

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

Inclusion Criteria:

  • Morphologic confirmation of a diagnosis of AML or ALL at MSKCC
  • Patients will have completed induction therapy, achieved 1st CR and will have completed any planned postremission therapy. Patients are not candidates for allogeneic stem cell transplantation. For purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available HLA matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by "good risk" features (For AML the following cyotogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated NPM1 and negative for tandem duplication of FLT-3. For ALL: T cell phenotype of any B lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st CR would not be offered as standard of care.
  • Alternatively, those patients greater than or equal to 60 years of age who have achieved 1st CR and in whom no further postremission chemotherapy is planned may be enrolled
  • Patients must have documented WT1 + disease. For purpose of this study, this is defined as detectable presence of any WT1 transcript via RT-PCR on a bone marrow performed at MSKCC within 4 weeks prior to the administration of the first dose of vaccine.
  • Patients must be within 2 years of achieving CR following chemotherapy
  • At least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
  • Age > or = to 18 years
  • Karnofsky performance status > or = to 50%
  • Hematologic parameters:

Absolute neutrophil count (ANC) > or = to 1000/μl

  • Platelets > 50k/ μl

Biochemical parameters:

  • Total bilirubin < or = to 2.0 mg/dl AST and ALT < or = to 2.5 x upper limits of normal
  • Creatinine < or = to 2.0 mg/dl

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients with documented evidence of leptomeningeal disease
  • Patients who have undergone autologous or allogeneic stem cell transplantation
  • Patients with active infection requiring systemic antimicrobials
  • Patients taking systemic corticosteroids
  • Patients with serious unstable medical illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266083

Contacts
Contact: Peter Maslak, MD 212-639-5518
Contact: Renier Brentjens, MD, PhD 212-639-7053

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue Recruiting
New York, New York, United States, 10021
Contact: Peter Maslak, MD    212-639-5518      
Contact: Renier Brentjens, MD, PhD    212-639-7053      
Principal Investigator: Peter Maslak, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Peter Maslak, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01266083     History of Changes
Other Study ID Numbers: 10-143
Study First Received: December 21, 2010
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
MONTANIDE ISA 51
WT1 PEPTIDE SPECIFIC T CELLS
vaccine
10-143

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014