Clinical Trials /

WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation

NCT01827137

Description:

The purpose of this study is to see if the investigator can help the immune system to work against myeloma. Because cancer is produced by the patients own body, the immune system does not easily recognize and fight cancer cells. The immune system needs to be "trained" to do this. This disease has been selected for this study because the Wilms Tumor 1 (WT1) protein is often present in myeloma cells. WT1 is a gene that is involved in the normal development of kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved in the development of cancer. This study will determine whether the WT1 vaccine causes an immune response which is safe and able to keep the myeloma from coming back.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Unknown status

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
  • Official Title: A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation

Clinical Trial IDs

  • ORG STUDY ID: 12-288
  • NCT ID: NCT01827137

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
WT1 Analog Peptide Vaccinevaccine
Sargramostim (GM-CSF)vaccine
lenalidomidevaccine

Purpose

The purpose of this study is to see if the investigator can help the immune system to work against myeloma. Because cancer is produced by the patients own body, the immune system does not easily recognize and fight cancer cells. The immune system needs to be "trained" to do this. This disease has been selected for this study because the Wilms Tumor 1 (WT1) protein is often present in myeloma cells. WT1 is a gene that is involved in the normal development of kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved in the development of cancer. This study will determine whether the WT1 vaccine causes an immune response which is safe and able to keep the myeloma from coming back.

Trial Arms

NameTypeDescriptionInterventions
vaccineExperimentalVaccinations will be initiated 12-22 days following autologous stem cell transplantation. Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, & 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF 70 μg) injected subcutaneously on days -2 (± 1 day) & 0 of each vaccination. Note: during each vaccination, the Sargramostim (GM-CSF)& the vaccine emulsion will be administered to the same anatomical site. Patients will be observed for at least 30 minutes after vaccination. Patients, who are clinically stable (no active infection with fevers & no cardiovascular or respiratory compromise) & have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month. The use of post-stem cell transplant maintenance therapy is allowed starting 3 months or more after transplant.
  • WT1 Analog Peptide Vaccine
  • Sargramostim (GM-CSF)
  • lenalidomide

Eligibility Criteria

        Inclusion Criteria:

          -  Symptomatic multiple myeloma, ISS stage 1-3 with confirmed diagnosis of multiple
             myeloma at MSKCC

          -  Patients must be eligible to undergo autologous stem cell transplantation by standard
             institutional criteria

          -  Patients must have documented WT1 positive disease. For purpose of this study, this is
             defined as detectable presence of WT1 expression by immunohistochemistry or by WT1
             transcript via RT-PCR on a bone marrow or other plasma cell-related biopsy specimen
             prior to autologous stem cell transplantation. Bone marrow or other biopsy specimen
             from time of diagnosis from patients diagnosed at MSKCC or outside hospital may be
             requested for assessment of WT1 expression by IHC

          -  Age > or = to 18 years

          -  Karnofsky performance status > or = to 50%

          -  Hematologic parameters:

          -  Absolute neutrophil count (ANC) > or = to 1000/μl

          -  Platelets > 50k/ μl

          -  Biochemical parameters:

          -  Total bilirubin < than or = to 2.0 mg/dl

          -  AST and ALT < than or = to 2.5 x upper limits of normal

          -  Creatinine < than or = to 2.0 mg/dl

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Patients with active infection requiring systemic antimicrobials

          -  Patients taking systemic corticosteroids

          -  Patients with serious unstable medical illness

          -  Concurrent malignancies
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:response
Time Frame:12-14 weeks after the initial WT1 peptide vaccine
Safety Issue:
Description:Immune responses to WT1 peptides will be measured by intracellular interferon-γ production assay and MHC tetramer analyses, if available for patient's HLA-type.

Secondary Outcome Measures

Measure:disease-free survival
Time Frame:2 years
Safety Issue:
Description:
Measure:overall survival
Time Frame:2 years
Safety Issue:
Description:
Measure:toxicity profile
Time Frame:2 years
Safety Issue:
Description:Toxicity will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) The only toxicities captured outside of the SAEs reported will be all Grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.
Measure:WT1 expression
Time Frame:2 years
Safety Issue:
Description:Protein expression analysis for WT antigens will be done by immunohistochemistry (IHC) as follows: Monoclonal antibodies to CD138/Syndecan, co-express WT1 when staining WT1 mAB 6F-H2 will employed by the study specified research lab on S-631.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • WT1 Analog Peptide Vaccine
  • 12-288

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