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Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma 

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00398138
  Purpose

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.


Condition Intervention Phase
Leukemia
Lung Cancer
Malignant Mesothelioma
Myelodysplastic Syndromes
Peritoneal Cavity Cancer
Drug: WT-1 analog peptide vaccine
Drug: incomplete Freund's adjuvant
Drug: sargramostim
Procedure: diagnostic procedure
Procedure: flow cytometry
Procedure: immunoenzyme technique
Procedure: non-specific immune-modulator therapy
Procedure: non-tumor cell-derivative vaccine therapy
Procedure: polymerase chain reaction
Phase I

Genetics Home Reference related topics:   Bone Marrow Diseases  

MedlinePlus related topics:   Bone Marrow Diseases   Cancer   Leukemia, Adult Acute   Leukemia, Adult Chronic   Leukemia, Childhood   Lung Cancer   Mesothelioma  

ChemIDplus related topics:   Granulocyte-macrophage colony-stimulating factor   Sargramostim   Freund's adjuvant   Montanide ISA 51  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
     
Official Title:   Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and immunogenicity [ Designated as safety issue: Yes ]
  • Immune response as measured by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antileukemic effects [ Designated as safety issue: No ]
  • Clinical and molecular response [ Designated as safety issue: No ]
  • Antitumor response as measured by CT scan based on RECIST criteria [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTC v. 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:   20
Study Start Date:   October 2006
Estimated Primary Completion Date:   October 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and immunogenicity of the Wilms tumor-1 analog peptide vaccine in patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

Secondary

  • Determine the antitumor effects of this vaccine in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to disease type (acute myeloid leukemia [AML] or myelodysplastic syndromes [MDS] vs non-small cell lung cancer or mesothelioma).

Patients receive vaccine comprising Wilms-tumor 1 (WT-1) analog peptide emulsified in Montanide ISA-51 subcutaneously (SC) once in weeks 0, 4, 6, 8, 10, and 12 and sargramostim (GM-CSF) SC twice in weeks 0, 4, 6, 8, 10, and 12 (on the day of and 2 days prior to each vaccination). Patients who have an immunologic response and have no disease progression may receive up to 6 more vaccinations approximately 1 month apart.

Blood samples are collected at baseline, week 8, and week 14. Samples are examined by polymerase chain reaction (PCR) to measure levels of WT-1 and by T-cell proliferative response, delayed-type hypersensitivity against WT-1 peptides, or ELISPOT to measure immune response.

Bone marrow samples are collected from patients with AML or MDS at baseline and week 14. Samples are examined by PCR to measure levels of WT-1 and by multiparameter flow cytometry to measure residual disease.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

  • Cytologically or histologically confirmed diagnosis of 1 of the following:

    • Acute myeloid leukemia, meeting the following criteria:

      • Documented Wilms tumor-1 (WT-1)-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease with real-time quantitative reverse transcriptase-polymerase chain reaction (RQ-PCR)
      • Completed induction chemotherapy, achieved clinical remission, and completed postremission therapy OR achieved clinical remission and have no plans for further postremission chemotherapy (≥ 65 years of age)
    • Myelodysplastic syndromes, meeting the following criteria:

      • Documented WT-1-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease by RQ-PCR
      • International Prognostic Scoring System (IPSS) score of ≥ Int-2
      • Not a candidate for cytotoxic chemotherapy
    • Non-small cell lung cancer, meeting the following criteria:

      • Positive tumor staining for WT-1 in > 10% of cells
      • Stage III or IV disease
      • Completed chemotherapy, surgery, and/or radiotherapy
    • Mesothelioma, meeting the following criteria:

      • Positive tumor staining for WT-1 in > 10% of cells
      • Unresectable or relapsed disease
      • Chemo-naive or received 1 prior chemotherapy regimen
      • Malignant pleural mesothelioma or peritoneal mesothelioma
  • No leptomeningeal disease
  • No CNS involvement

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count > 50,000/mm³ (except for myelodysplastic syndromes where parameter is > 20,000/mm³ and not transfusion dependent)
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  • No serious unstable medical illness
<>PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy or radiotherapy
  • No concurrent systemic corticosteroids
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398138

Locations
     
United States, New York
      Memorial Sloan - Kettering Cancer Center           Recruiting
            New York, New York, United States, 10021
            Contact: Lee M. Krug, MD     212-639-8420        

Sponsors and Collaborators
     
Memorial Sloan-Kettering Cancer Center
     
National Cancer Institute (NCI)

Investigators
     
Principal Investigator:     Lee M. Krug, MD     Memorial Sloan-Kettering Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database 
 

Study ID Numbers:   CDR0000513334, MSKCC-06085
First Received:   November 9, 2006
Last Updated:   April 1, 2008
ClinicalTrials.gov Identifier:   NCT00398138
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
recurrent malignant mesothelioma  
adult acute myeloid leukemia in remission  
adult acute myeloid leukemia with 11q23 (MLL) abnormalities  
adult acute myeloid leukemia with inv(16)(p13;q22)  
adult acute myeloid leukemia with t(15;17)(q22;q12)  
adult acute myeloid leukemia with t(16;16)(p13;q22)  
adult acute myeloid leukemia with t(8;21)(q22;q22)  
     
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Precancerous Conditions
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Lung Neoplasms
Neoplasm Metastasis
Wilms Tumor
Acute myeloid leukemia, adult
Congenital Abnormalities
     
Acute myelocytic leukemia
Myelodysplastic syndromes
Non-small cell lung cancer
Hematologic Diseases
Wilms' tumor
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Myeloproliferative Disorders
Leukemia, Myeloid

Additional relevant MeSH terms:
Mesothelioma
Respiratory Tract Neoplasms
Neoplasms
Hemic and Lymphatic Diseases
Neoplasms by Site
Neoplasms by Histologic Type
     
Immunologic Factors
Respiratory Tract Diseases
Neoplasms, Mesothelial
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

***Source: http://www.cancer.gov/clinicaltrials***