- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398138
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Thoracic and Myeloid Neoplasms
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vaccine
Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities.
Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination.
Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration.
Patients will keep a logbook noting the time & placement of the injection.
Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site.
This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 2 years
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Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).
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2 years
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Immune Response
Time Frame: 2 years
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Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies.
Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides.
In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Lee M. Krug, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- 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
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- adult acute myeloid leukemia in remission
- advanced malignant mesothelioma
- recurrent malignant mesothelioma
- primary peritoneal cavity cancer
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Precancerous Conditions
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Syndrome
- Myelodysplastic Syndromes
- Lung Neoplasms
- Leukemia
- Preleukemia
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Sargramostim
- Freund's Adjuvant
Other Study ID Numbers
- 06-085
- P30CA008748 (U.S. NIH Grant/Contract)
- P01CA023766 (U.S. NIH Grant/Contract)
- MSKCC-06085
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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