Verified by National Cancer Institute (NCI), March 2008
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
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National Cancer Institute (NCI) |
NCT00398138 |
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.
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Leukemia
Lung Cancer
Malignant
Mesothelioma
Myelodysplastic Syndromes
Peritoneal Cavity Cancer
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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
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Phase I
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Genetics Home Reference related topics:
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Bone Marrow Diseases
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MedlinePlus related topics:
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Bone Marrow Diseases
Cancer
Leukemia, Adult Acute
Leukemia, Adult Chronic
Leukemia, Childhood
Lung Cancer
Mesothelioma
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ChemIDplus related topics:
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Granulocyte-macrophage colony-stimulating factor
Sargramostim
Freund's adjuvant
Montanide ISA 51
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U.S. FDA Resources
Study Type: |
Interventional |
Study Design: |
Treatment |
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Official Title: |
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms |
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) |
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
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.
Ages Eligible for Study: |
18 Years and older |
Genders Eligible for Study: |
Both |
Accepts Healthy Volunteers: |
No |
DISEASE CHARACTERISTICS:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398138
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Memorial Sloan - Kettering Cancer Center |
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New York, New York, United States, 10021 |
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Contact: Lee M. Krug, MD 212-639-8420 |
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Memorial Sloan-Kettering Cancer Center |
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National Cancer Institute (NCI) |
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Principal Investigator: |
Lee M. Krug, MD |
Memorial Sloan-Kettering Cancer Center |
More Information
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Clinical trial summary from the National Cancer Institute's PDQ® database 
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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) |
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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 |
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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 |
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Acute myelocytic leukemia |
Myelodysplastic syndromes |
Non-small cell lung cancer |
Hematologic Diseases |
Wilms' tumor |
Myelodysplastic Syndromes |
Myelodysplasia |
Acute myelogenous leukemia |
Myeloproliferative Disorders |
Leukemia, Myeloid |
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Additional relevant MeSH terms:
Mesothelioma |
Respiratory Tract Neoplasms |
Neoplasms |
Hemic and Lymphatic Diseases |
Neoplasms by Site |
Neoplasms by Histologic Type |
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Immunologic Factors |
Respiratory Tract Diseases |
Neoplasms, Mesothelial |
Physiological Effects of Drugs |
Adjuvants, Immunologic |
Pharmacologic Actions |
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***Source: http://www.cancer.gov/clinicaltrials*** |