View Clinical Trial (Medical Research Study)
Randomized Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in Patients With Malignant Pleural Mesothelioma (MPM) After Completion of Combined Modality Therapy
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Malignant Pleural Mesothelioma |
| Purpose: |
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The doctors are testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents the
mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that
regulates gene expression and causes cell growth. Mesothelioma tumors generally have high
levels of WT1. The patient will be assigned to one of two treatment groups. One group will
receive non-specific immunotherapy with medications called Montanide and Sargramostim
(Granulocyte Macrophage Colony Stimulating Factor, GM-CSF). The other group will receive
more specific immunotherapy with the WT1 vaccine plus Montanide and GM-CSF. Both Montanide
and GM-CSF are commonly given along with vaccines because they have a general effect in
boosting the immune response. Some researchers believe that this general increase in the
immune system may have some effect in treating cancer. Some studies using GM-CSF with
melanoma vaccines have suggested that it could lessen the effects of the vaccine. The
addition of the WT1 proteins makes this therapy more directed to mesothelioma. The
combination of WT1 vaccine with Montanide and GM-CSF has been tested in a prior trial
including 9 patients with advanced mesothelioma. In that trial, the vaccine was safe and
caused an immune response. The patient will have a 50% chance of being in each group.
Neither the patient nor the doctor will be aware of which group they are in.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at
participating institution.
- Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
- Completion of multimodality therapy. This must include surgical resection by either
pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be
performed with the intent of complete resection, though patients with an R1 resection
will still be eligible. Patients should have also received treatment with
chemotherapy and/or radiation. Patients with an R2 resection are also eligible as
long as the site of residual disease is treated post-operatively with radiotherapy.
- 4-12 weeks since completion of combined modality therapy.
- Age > or = to 18 years
- Karnofsky performance status > or = to 70%
- Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or
= to 50K/mcL.
- Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to
2.5 x upper limits of normal, Creatinine < or = to 2.0 mg/dl.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with active infection requiring systemic antibiotics, antiviral, or
antifungal treatments.
- Patients with a serious unstable medical illness or another active cancer.
- Patients taking systemic corticosteroids.
- Patients with an immunodeficiency syndrome.
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| NCT ID: |
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NCT01265433 |
| Primary Contact: |
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Principal Investigator
Lee Krug, MD
Memorial Sloan-Kettering Cancer Center
Lee Krug, MD
Phone: 646-888-4201
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| Backup Contact: |
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Valeria Rusch, MD
Phone: 212-639-5873
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| Location Contact: |
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New York, New York 10065
United States
Lee Krug, MD
Phone: 646-888-4201
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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