Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms

NCT00665002 | Completed Results DMC

• 3 other identifiers: MCC-15025INNO-305 WT-1105946
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia

Keywords

Myeloid; Monocytic; Hematopoietic; Neoplasms; Acute Myelogenous Leukemia; AML; Myelodysplastic Syndrome; MDS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  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.

  12 weeks to 6 months

Secondary Outcomes (1)

• Participants Whose Samples Demonstrated Immunological Response After Vaccination

  12 weeks

Study Arms (1)

WT-1 Analog Peptide Vaccine

EXPERIMENTAL

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.

Biological: WT-1; Drug: Montanide; Drug: Sargramostim (GM-CSF)

Interventions

WT-1 BIOLOGICAL

Immune responses were to be evaluated at weeks 6 and 12 via delayed-type hypersensitivity, CD4 T cell proliferation, CD4 and CD8 T cell interferon release, as well as by bone marrow cytogenetics including polymerase chain reaction (PCR) to look for molecular evidence of disease. Patients who had an immunologic response and had not had disease progression could continue with up to 6 more vaccinations administered approximately every month. In that case, patients were to be reevaluated with bone marrows/immunologic studies after the 9th and 12th vaccination. In addition, patients would undergo evaluations for residual disease including immunohistochemistry and/or quantitative polymerase chain reaction (RQ-PCR) for WT-1 expression (on selected patients), and multiparameter flow cytometry (AML/ MDS).

Also known as: Analog Peptide Vaccine

WT-1 Analog Peptide Vaccine

Montanide DRUG

The WT-1 vaccine is given with another substance, called Montanide, which clumps the WT-1 vaccine and thereby improves the immune response.

WT-1 Analog Peptide Vaccine

Sargramostim (GM-CSF) DRUG

GM-CSF was administered at a dose 70 mcg (140ul) as a subcutaneous injection at the site of vaccination on day -2 and day 0.

WT-1 Analog Peptide Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Innovive Pharmaceuticals: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Shallis 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 DERIVED

MeSH Terms

Conditions

Leukemia; Neoplasms; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Monatide (IMS 3015); sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Jeffrey E. Lancet, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jeffrey.lancet@moffitt.org

813-745-6841

Study Officials

• Jeffrey Lancet, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2015
• Last Updated: February 27, 2015
• Results First Posted: July 24, 2014

Record last verified: 2015-02

Locations

US (1)