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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***

 
   
 
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