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Trial record 6 of 24 for:    WAGR

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827137
First Posted: April 9, 2013
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
IND transferred to Sellas
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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.


Condition Intervention
Multiple Myeloma Biological: WT1 Analog Peptide Vaccine Biological: Sargramostim (GM-CSF) Drug: lenalidomide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • response [ Time Frame: 12-14 weeks after the initial WT1 peptide vaccine ]
    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:
  • disease-free survival [ Time Frame: 2 years ]
  • overall survival [ Time Frame: 2 years ]
  • toxicity profile [ Time Frame: 2 years ]
    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.

  • WT1 expression [ Time Frame: 2 years ]
    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.


Enrollment: 22
Actual Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine
Vaccinations 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.
Biological: WT1 Analog Peptide Vaccine Biological: Sargramostim (GM-CSF) Drug: lenalidomide
Optional lenalidomide maintenance starting 3-months post auto SCT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827137


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
IND transferred to Sellas
Investigators
Principal Investigator: Guenther Koehne, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01827137     History of Changes
Other Study ID Numbers: 12-288
First Submitted: April 2, 2013
First Posted: April 9, 2013
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
WT1 Analog Peptide Vaccine
12-288

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents