Clinical Trials for Mesothelioma Patients—Vaccine Therapy and GM-CSF: Study Outline

Read about the outline for a concurrent therapy for a current clinical trial to test vaccine therapy GM-CSF on mesothelioma patients. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

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.

Courtesy of ClinicalTrials.gov, a service of the U.S. National Institutes of Health

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