A Phase 1 interventional study of WT-1 analog peptide vaccine and incomplete Freund's adjuvant in Leukemia, Lung Cancer and Malignant Mesothelioma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-03-02.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 22 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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DISEASE CHARACTERISTICS:
Cytologically or histologically confirmed diagnosis of 1 of the following:
Acute myeloid leukemia, meeting the following criteria:
Myelodysplastic syndromes, meeting the following criteria:
Non-small cell lung cancer, meeting the following criteria:
Mesothelioma, meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Biological: WT-1 analog peptide vaccine · Biological: incomplete Freund's adjuvant · Biological: sargramostim · Genetic: polymerase chain reaction · Other: flow cytometry · Other: immunoenzyme technique
Safety
Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).
Time frame: 2 years
Immune Response
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.
Time frame: 2 years
| Milestone | Vaccine |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).
| participants | Vaccine |
|---|---|
| Safety | 10 |
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.
| participants | Vaccine |
|---|---|
| Immune Response | 10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccine | — | 3/10 (30%) | 10/10 (100%) |
| Event | Vaccine |
|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/10 |
| Edema: head and neckVascular disorders | 1/10 |
| SyncopeNervous system disorders | 1/10 |
| Event | Vaccine |
|---|---|
| Glucose, high (hyperglycemia)Metabolism and nutrition disorders | 10/10 |
| Albumin, low (hypoalbuminemia)Metabolism and nutrition disorders | 6/10 |
| HemoglobinMetabolism and nutrition disorders | 6/10 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 4/10 |
| Leukocytes (total WBC)Infections and infestations | 4/10 |
| PlateletsBlood and lymphatic system disorders | 4/10 |
| Neutrophils/granulocytes (ANC/AGC)Infections and infestations | 2/10 |
| LymphopeniaBlood and lymphatic system disorders | 1/10 |
| Age, Categorical(Participants) | Vaccine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Vaccine |
|---|---|
| Female | 2 |
| Male | 8 |
| Region of Enrollment(participants) | Vaccine |
|---|---|
| United States | 10 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center