{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).","groups":[{"description":"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.\n\nWT-1 analog peptide vaccine","id":"OG000","title":"Vaccine"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 years","title":"Safety","type":"PRIMARY","unitOfMeasure":"participants"}