WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | April 2017 |
| Contact: | Guenther Koehne, MD PhD |
| Phone: | 212-639-8599 |
A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Guenther Koehne, MD, PhD
Phone: 212-639-8599
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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