Clinical trial · Interventional
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms
NCT00665002CI-TRIAL-00016948completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the WT-1 vaccine causes an immune response and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system can recognize as abnormal.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Montanide | Drug | — | UNRESOLVED |
| Sargramostim (GM-CSF) | Drug | — | UNRESOLVED |
| WT-1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WT-1 Analog Peptide Vaccine
- description
- Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
- interventionNames
- Biological: WT-1
- Drug: Montanide
- Drug: Sargramostim (GM-CSF)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- 12 weeks to 6 months
- description
- Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic or histologic diagnosis of acute myelogenous leukemia or myelodysplastic syndrome confirmed at Moffitt Cancer Center. * Patients with acute myelogenous leukemia will have completed induction chemotherapy, achieved first complete remission (CR) 1 or 2, and will have completed any planned postremission therapy (at discretion of treating physician),with no plan for allogenic or autologous transplant. * Patients with myelodysplastic syndrome who according to the International Prognostic Scoring System (IPSS) are category Int-2 or greater, with disease that relapsed, progressed, or not responded to at least 1 prior course of approved therapy for MDS (i.e. hypomethylating agent or lenalidomide). * Patients with AML/MDS must have documented WT-1 + disease. For purposes of this study, this may be either the demonstration of WT-1 protein on a pretreatment bone marrow biopsy or detectable disease with RQ-PCR. For patients in whom a bone marrow aspirate is not available or possible (e.g. "dry tap"), a peripheral blood sample may be used for WT-1 screening. In such cases, 10 cc of peripheral blood will be collected in a heparinized tube. * At least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination. * Karnofsky performance status ≥ 70% * Hematologic parameters: * Absolute neutrophil count ≥ 1000/mcL (except for MDS, for which the parameter is ≥ 500/mcL) * Platelets \> 50 K/mcL (except for MDS for which the parameter is \> 25 K/mcL and not transfusion dependent) * Biochemical parameters: * Total bilirubin ≤ 2.0 mg/dl * Aspartic transaminase (AST) and Alanine transaminase (ALT) ≤ 2.5 x upper limits of normal * Creatinine ≤ 2.0 mg/dl Exclusion Criteria: * Pregnant or lactating women * Patients with leptomeningeal disease * Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments * Patients with serious unstable medical illness * Patients taking systemic corticosteroids * Patients with central nervous system (CNS) involvement with cancer/leukemia
References
Publications (1)
- DERIVEDShallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637. PMID 33394722